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    HP:0001928: Abnormality of coagulation

    Developed by Shray Alag, The Harker School
    Sections: Correlations, Clinical Trials, and HPO

    Correlations computed by analyzing all clinical trials.

    Navigate: Clinical Trials and HPO


    Correlated Drug Terms (33)


    Name (Synonyms) Correlation
    drug582 COVID-19 Wiki 0.35
    drug4048 therapeutic plasmaexchnage Wiki 0.26
    drug3359 Thrombin Generation Assay (TGA) Wiki 0.26
    Name (Synonyms) Correlation
    drug3320 The POP02 study is collecting bodily fluid samples (i.e., whole blood, effluent samples) of children prescribed the following drugs of interest per standard of care: Wiki 0.26
    drug596 COVID-19 PCR and Serology Wiki 0.26
    drug3598 Wearable Medical Device (Empatica E4) Wiki 0.26
    drug3091 Sonclot Coagulation and platelet function Analyzer SCP1, Sienco, USA Wiki 0.26
    drug586 COVID-19 Breastfeeding Support Wiki 0.26
    drug2341 PLACEBO GROUP Wiki 0.26
    drug1653 Intermediate dose thromboprophylaxis Wiki 0.26
    drug2658 Pulse Oximeter Wiki 0.26
    drug3262 TRV027 Wiki 0.26
    drug3360 Thrombin generation test assay Wiki 0.26
    drug3361 Thrombomodulin Modified Thrombin Generation Assay (TGA-TM) Wiki 0.26
    drug2001 Microcrystalline Cellulose, NF Wiki 0.26
    drug4017 sodium chloride 0.9% Wiki 0.26
    drug579 COVID Watch Wiki 0.26
    drug595 COVID-19 PCR Swab Wiki 0.26
    drug597 COVID-19 PCR and serology testing Wiki 0.26
    drug1277 Fibrin generation markers assays Wiki 0.26
    drug3969 pulse oximeter Wiki 0.26
    drug593 COVID-19 IgG/IgM Rapid Test Cassette test (Healgen Scientific, Houston, Texas, USA) Wiki 0.26
    drug591 COVID-19 FACILITY Wiki 0.26
    drug3332 Therapeutic Anticoagulation Wiki 0.26
    drug584 COVID-19 Antibody testing Wiki 0.26
    drug3145 Standard of Care thromboprophylaxis Wiki 0.26
    drug357 BCG GROUP Wiki 0.26
    drug583 COVID-19 Androgen Sensitivity Test (CoVAST) Wiki 0.26
    drug2677 Quantra System Wiki 0.26
    drug587 COVID-19 Convalescent Plasma Wiki 0.23
    drug3337 Therapeutic anticoagulation Wiki 0.18
    drug673 Camostat Mesylate Wiki 0.18
    drug1166 Enoxaparin Wiki 0.13

    Correlated MeSH Terms (30)


    Name (Synonyms) Correlation
    D020141 Hemostatic Disorders NIH 1.00
    D001778 Blood Coagulation Disorders NIH 1.00
    D004211 Disseminated Intravascular Coagulation NIH 0.35
    Name (Synonyms) Correlation
    D009080 Mucocutaneous Lymph Node Syndrome NIH 0.26
    D001997 Bronchopulmonary Dysplasia NIH 0.26
    D008595 Menorrhagia NIH 0.26
    D006929 Hyperaldosteronism NIH 0.26
    D014552 Urinary Tract Infections NIH 0.26
    D054559 Hyperphosphatemia NIH 0.26
    D004314 Down Syndrome NIH 0.26
    D000309 Adrenal Insufficiency NIH 0.26
    D007008 Hypokalemia NIH 0.26
    D001289 Attention Deficit Disorder with Hyperactivity NIH 0.15
    D006470 Hemorrhage NIH 0.15
    D012769 Shock, NIH 0.10
    D054556 Venous Thromboembolism NIH 0.09
    D011655 Pulmonary Embolism NIH 0.07
    D004617 Embolism NIH 0.06
    D006973 Hypertension NIH 0.06
    D013923 Thromboembolism NIH 0.06
    D004194 Disease NIH 0.05
    D016638 Critical Illness NIH 0.03
    D011024 Pneumonia, Viral NIH 0.03
    D014777 Virus Diseases NIH 0.03
    D011014 Pneumonia NIH 0.03
    D013577 Syndrome NIH 0.03
    D007239 Infection NIH 0.02
    D045169 Severe Acute Respiratory Syndrome NIH 0.02
    D003141 Communicable Diseases NIH 0.02
    D018352 Coronavirus Infections NIH 0.02

    Correlated HPO Terms (11)


    Name (Synonyms) Correlation
    HP:0005521 Disseminated intravascular coagulation HPO 0.35
    HP:0002905 Hyperphosphatemia HPO 0.26
    HP:0002900 Hypokalemia HPO 0.26
    Name (Synonyms) Correlation
    HP:0000846 Adrenal insufficiency HPO 0.26
    HP:0000132 Menorrhagia HPO 0.26
    HP:0000859 Hyperaldosteronism HPO 0.26
    HP:0007018 Attention deficit hyperactivity disorder HPO 0.15
    HP:0002204 Pulmonary embolism HPO 0.07
    HP:0000822 Hypertension HPO 0.06
    HP:0001907 Thromboembolism HPO 0.05
    HP:0002090 Pneumonia HPO 0.03

    Clinical Trials

    Navigate: Correlations   HPO

    There are 15 clinical trials


    1 Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs

    The study investigators are interested in learning more about how drugs, that are given to children by their health care provider, act in the bodies of children and young adults in hopes to find the most safe and effective dose for children. The primary objective of this study is to evaluate the PK of understudied drugs currently being administered to children per SOC as prescribed by their treating provider.

    NCT04278404
    Conditions
    1. Coronavirus Infection (COVID-19)
    2. Pulmonary Arterial Hypertension
    3. Urinary Tract Infections in Children
    4. Hypertension
    5. Pain
    6. Hyperphosphatemia
    7. Primary Hyperaldosteronism
    8. Edema
    9. Hypokalemia
    10. Heart Failure
    11. Hemophilia
    12. Menorrhagia
    13. Insomnia
    14. Pneumonia
    15. Skin Infection
    16. Arrythmia
    17. Asthma in Children
    18. Bronchopulmonary Dysplasia
    19. Adrenal Insufficiency
    20. Fibrinolysis; Hemorrhage
    21. Attention Deficit Hyperactivity Disorder
    22. Multisystem Inflammatory Syndrome in Children (MIS-C)
    23. Kawasaki Disease
    24. Coagulation Disorder
    25. Down Syndrome
    Interventions
    1. Drug: The POP02 study is collecting bodily fluid samples (i.e., whole blood, effluent samples) of children prescribed the following drugs of interest per standard of care:
    MeSH:Infection Communicable Diseases Urinary Tract Infections Coronavirus Infections Severe Acute Respiratory Syndrome Bronchopulmonary Dysplasia Down Syndrome Menorrhagia Hypertension Hemostatic Disorders Mucocutaneous Lymph Node Syndrome Blood Coagulation Disorders Hyperphosphatemia Hypokalemia Adrenal Insufficiency Hyperaldosteronism Disease Syndrome Hemorrhage Attention Deficit Disorder with Hyperactivity
    HPO:Abnormality of coagulation Abnormality of the coagulation cascade Adrenal insufficiency Attention deficit hyperactivity disorder Hyperaldosteronism Hyperphosphatemia Hypertension Hypokalemia Menorrhagia Primary hyperaldosteronism

    Primary Outcomes

    Measure: Clearance (CL) or apparent oral clearance (CL/F) as measured by PK sampling

    Time: Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.

    Measure: Volume of distribution (V) or apparent oral volume of distribution (V/F) as measured by PK sampling

    Time: Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.

    Measure: Elimination rate constant (ke) as measured by PK sampling

    Time: Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.

    Measure: Half-life (t1/2) as measured by PK sampling

    Time: Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.

    Measure: Absorption rate constant (ka) as measured by PK sampling

    Time: Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.

    Measure: AUC (area under the curve) as measured by PK sampling

    Time: Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.

    Measure: Maximum concentration (Cmax) as measured by PK sampling

    Time: Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.

    Measure: Time to achieve maximum concentration (Tmax) as measured by PK sampling

    Time: Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.
    2 Coagulation Assays in the Critically Ill Patient: a New Approach Using the Thrombomodulin-modified Thrombin Generation Assay (TGA-TM)

    Inflammation and abnormalities in laboratory coagulation tests are inseparably tied. For example, coagulation abnormalities are nearly universal in septic patients. Coagulation disorders have also been reported in many patients with severe courses of Coronavirus disease 2019 (Covid-19). But it is difficult to assess these changes. Global coagulation tests have been shown to incorrectly assess in vivo coagulation in patients admitted to intensive care units. But other tests are available. Thrombin generation assay (TGA) is a laboratory test which allows the assessment of an individual's potential to generate thrombin. But also in conventional TGA the protein C system is hardly activated because of the absence of endothelial cells (containing natural thrombomodulin) in the plasma sample. Therefore the investigators add recombinant human thrombomodulin to a conventional TGA. Thereby the investigators hope to be able to depict in vivo coagulation more closely than global coagulation tests do.

    NCT04356144
    Conditions
    1. Disseminated Intravascular Coagulation
    2. Critical Illness
    3. Sars-CoV2
    4. Viral Infection
    5. Coagulation Disorder, Blood
    6. Covid19
    Interventions
    1. Diagnostic Test: Thrombin Generation Assay (TGA)
    2. Diagnostic Test: Thrombomodulin Modified Thrombin Generation Assay (TGA-TM)
    MeSH:Infection Virus Diseases Hemostatic Disorders Blood Coagulation Disorders Disseminated Intravascular Coagulation Critical Illness
    HPO:Abnormality of coagulation Abnormality of the coagulation cascade Disseminated intravascular coagulation

    Primary Outcomes

    Description: nM;

    Measure: ETP (AUC) without rhThrombomodulin (rhTM)

    Time: 6 months

    Description: nM;

    Measure: ETP (AUC) with rhThrombomodulin (rhTM)

    Time: 6 months

    Description: Ratio of endogenous thrombin potential (ETP) with rhTM to ETP without rhTM

    Measure: ETP-ratio

    Time: 6 months

    Description: Comparison of ETP-ratios from ICU patients and ETP-ratios from citrated plasma samples from healthy donors

    Measure: ETP-Normalisation

    Time: 6 months
    3 Analysis of the Coagulopathy Developed by COVID-19 Infected Patients: Thrombin Generation Potential in COVID-19 Infected Patients

    Increased D-dimers at admission of COVID-19 infected patients entering hospital due to a severe disease is a risk factor for death. Understanding this acquired coagulopathy is a prerequisite before specific interventional studies. The study investigators aim to apply a normalized and automated thrombin generation test (TGT), developed for testing the thrombotic risk (triggered by 5 pM Tissue Factor, with a purified thrombomodulin (TM) challenge) and to study its association with survival.

    NCT04356950
    Conditions
    1. Sepsis
    2. Blood Coagulation Disorders
    3. Thrombin
    4. Disseminated Intravascular Coagulation
    5. COVID-19
    Interventions
    1. Other: Thrombin generation test assay
    2. Other: Fibrin generation markers assays
    MeSH:Hemostatic Disorders Blood Coagulation Disorders Disseminated Intravascular Coagulation
    HPO:Abnormality of coagulation Abnormality of the coagulation cascade Disseminated intravascular coagulation

    Primary Outcomes

    Description: Death yes/no during hopstilization, 28 days after admittence

    Measure: 28-day survival rate

    Time: 1 month

    Description: Seconds; without (TM-) and with (TM+) purified thrombomodulin

    Measure: Absolute thrombin generation test latent period

    Time: Day 0

    Description: %; without (TM-) and with (TM+) purified thrombomodulin

    Measure: Relative thrombin generation test latent period compared to reference plasma

    Time: Day 0

    Description: nmol/s; without (TM-) and with (TM+) purified thrombomodulin

    Measure: Absolute thrombin generation test initial velocity

    Time: Day 0

    Description: %; without (TM-) and with (TM+) purified thrombomodulin

    Measure: Relative thrombin generation test initial velocity compared to reference plasma

    Time: Day 0

    Description: %; without (TM-) and with (TM+) purified thrombomodulin

    Measure: Relative thrombin generation test peak thrombin compared to reference plasma

    Time: Day 0

    Description: nmol/L; without (TM-) and with (TM+) purified thrombomodulin

    Measure: Absolute thrombin generation test peak thrombin

    Time: Day 0

    Description: Seconds; without (TM-) and with (TM+) purified thrombomodulin

    Measure: Absolute thrombin generation test peak thrombin time

    Time: Day 0

    Description: %; without (TM-) and with (TM+) purified thrombomodulin

    Measure: Relative thrombin generation test peak thrombin time compared to reference plasma

    Time: Day 0

    Description: seconds; without (TM-) and with (TM+) purified thrombomodulin

    Measure: Absolute thrombin generation test total thrombin generation time

    Time: Day 0

    Description: %; without (TM-) and with (TM+) purified thrombomodulin

    Measure: Relative thrombin generation test total thrombin generation time compared to reference plasma

    Time: Day 0

    Description: Seconds; without (TM-) and with (TM+) purified thrombomodulin

    Measure: Absolute thrombin generation test endogenous thrombin potential

    Time: Day 0

    Description: %; without (TM-) and with (TM+) purified thrombomodulin

    Measure: Relative thrombin generation test endogenous thrombin potential compared to reference plasma

    Time: Day 0

    Secondary Outcomes

    Description: Death yes/no

    Measure: 3-month survival rate

    Time: 3 months

    Description: Yes/no

    Measure: Transfer to intensive care unit during hospitalization

    Time: 3 months

    Description: Yes/no (deep vein thrombosis, pulmonary embolism, atherothrombosis flare, arterial thrombosis)

    Measure: Thrombotic complication during hospitalization

    Time: 3 months

    Description: µg / L, assayed by automated enzyme linked fluorescent assay (Vidas® D-dimers Exclusion ™ II)

    Measure: Plasma concentrations of D-dimers

    Time: Day 0

    Description: mg / L, measured by automated immunoagglutination (STA®-Liatest® FM)

    Measure: Plasma concentrations of soluble fibrin monomers

    Time: Day 0
    4 COVID-19-associated Coagulopathy: Safety and Efficacy of Prophylactic Anticoagulation Therapy in Hospitalized Adults With COVID-19

    This prospective, randomized, open-label, multi-center interventional study is designed to compare the safety and efficacy of two LMWH dosing protocols in patients admitted to the University of Iowa Hospitals with COVID-19 who meet the modified ISTH Overt DIC criteria score ≥3. Patients will be randomized to standard prophylactic dose LMWH (standard of care arm) or intermediate-dose LMWH (intervention arm).

    NCT04360824
    Conditions
    1. COVID 19 Associated Coagulopathy
    Interventions
    1. Drug: Intermediate dose thromboprophylaxis
    2. Drug: Standard of Care thromboprophylaxis
    MeSH:Hemostatic Disorders Blood Coagulation Disorders
    HPO:Abnormality of coagulation Abnormality of the coagulation cascade

    Primary Outcomes

    Description: Risk of all-cause mortality

    Measure: Mortality

    Time: 30 Days post intervention

    Secondary Outcomes

    Description: Risk of ISTH defined major bleeding

    Measure: Major Bleeding

    Time: 30 Days post intervention

    Description: Risk of ischemic stroke, myocardial infarction and/or limb ischemia

    Measure: Arterial Thrombosis

    Time: 30 Days post intervention

    Description: Risk of symptomatic venous thromboembolism

    Measure: Venous Thromboembolism

    Time: 30 Days post intervention

    Description: duration of intensive care measures

    Measure: ICU admission, intubation/ventilation

    Time: 30 Days post intervention

    Description: The number of units of packed red blood cells transfused

    Measure: Packed Red Blood Cell Transfusions

    Time: 30 Days post intervention

    Description: The number of units of platelets transfused

    Measure: Platelet Transfusions

    Time: 30 Days post intervention

    Description: The number of units of Fresh Frozen Plasma Transfused

    Measure: Fresh Frozen Plasma Transfusions

    Time: 30 Days post intervention

    Description: The number of units of Cryoprecipitate Transfused

    Measure: Cryoprecipitate Transfusions

    Time: 30 Days post intervention

    Description: The number of units of Prothrombin Complex ConcentrateTransfused

    Measure: Prothrombin Complex Concentrate Transfusions

    Time: 30 Days post intervention

    Other Outcomes

    Description: Will be performed in stored plasma using Calibrated Automated Thrombogram. The endogenous thrombin potential will be calculated in units of nM.Min.

    Measure: The endogenous thrombin potential will be determined within 24 hours of randomization and weekly for 30 days or until hospital discharge

    Time: 30 days post intervention

    Description: These assays will be performed in stored plasma. Quantification of cfDNA will be performed using Qubit dsDNA HS Assay kit. Histones H4, citrullinated-histone and DNA-myeloperoxidase will be measured using commercially available ELISA kit.

    Measure: Plasma levels of cell-free DNA will be determined within 24 hours of randomization and weekly for 30 days or until hospital discharge

    Time: 30 days post intervention

    Description: will be measured in stored plasma using a commercially available ELISA kit.

    Measure: PAI-1

    Time: 30 days post intervention
    5 Coagulopathy of COVID-19: A Pragmatic Randomized Controlled Trial of Therapeutic Anticoagulation Versus Standard Care as a Rapid Response to the COVID-19 Pandemic (RAPID COVID COAG)

    Coagulopathy of COVID-19 afflicts approximately 20% of patients with severe COVID-19 and is associated with need for critical care and death. COVID-19 coagulopathy is characterized by elevated D-dimer, an indicator of fibrin formation and clot lysis, and a mildly prolonged prothrombin time, suggestive of coagulation consumption. To date, it seems that COVID-19 coagulopathy manifests with thromboembolism, thus anticoagulation may be of benefit. We propose to conduct a parallel pragmatic multi-centre open-label randomized controlled trial to determine the effect of therapeutic anticoagulation compared to standard care in hospitalized patients admitted for COVID-19 with an elevated D-dimer.

    NCT04362085
    Conditions
    1. COVID-19
    Interventions
    1. Drug: Therapeutic Anticoagulation
    MeSH:Hemostatic Disorders Blood Coagulation Disorders
    HPO:Abnormality of coagulation Abnormality of the coagulation cascade

    Primary Outcomes

    Description: Composite outcome of ICU admission (yes/no), non-invasive positive pressure ventilation (yes/no), invasive mechanical ventilation (yes/no), or all-cause death (yes/no) up to 28 days.

    Measure: Composite outcome of ICU admission (yes/no), non-invasive positive pressure ventilation (yes/no), invasive mechanical ventilation (yes/no), or all-cause death (yes/no) up to 28 days.

    Time: Up to 28 days

    Secondary Outcomes

    Description: All-cause death

    Measure: All-cause death

    Time: Up to 28 days

    Description: Composite outcome of ICU admission or all-cause death

    Measure: Composite outcome of ICU admission or all-cause death

    Time: Up to 28 days

    Description: Major bleeding as defined by the ISTH Scientific and Standardization Committee (ISTH-SSC) recommendation

    Measure: Major bleeding

    Time: Up to 28 days

    Description: Red Blood Cell transfusion (greater than or equal to 1 unit)

    Measure: Number of participants who received red blood cell transfusion

    Time: Up to 28 days

    Description: Transfusion of platelets, frozen plasma, prothrombin complex concentrate, cryoprecipitate and/or fibrinogen concentrate

    Measure: Number of participants with transfusion of platelets, frozen plasma, prothrombin complex concentrate, cryoprecipitate and/or fibrinogen concentrate.

    Time: Up to 28 days

    Description: Renal replacement therapy defined as continuous renal replacement therapy or intermittent hemodialysis

    Measure: Renal replacement therapy

    Time: Up to 28 days

    Description: Hospital-free days alive up to day 28

    Measure: Number of hospital-free days alive up to day 28

    Time: Up to 28 days

    Description: ICU-free days alive up to day 28

    Measure: Number of ICU-free days alive up to day 28

    Time: Up to 28 days

    Description: Ventilator-free days alive up to day 28

    Measure: Number of ventilator-free days alive up to day 28

    Time: Up to 28 days

    Description: Organ support-free days alive up to day 28

    Measure: Number of organ support-free days alive up to day 28

    Time: Up to 28 days

    Description: Venous thromboembolism

    Measure: Number of participants with venous thromboembolism

    Time: Up to 28 days

    Description: Arterial thromboembolism

    Measure: Number of participants with arterial thromboembolism

    Time: Up to 28 days

    Description: Heparin induced thrombocytopenia

    Measure: Number of participants with heparin induced thrombocytopenia

    Time: Up to 28 days

    Description: D-dimer

    Measure: Changes in D-dimer up to day 3

    Time: Up to day 3
    6 Randomised Controlled Trial Comparing High Versus Low LMWH Dosages in Hospitalized Patients With Severe COVID-19 Pneumonia and Coagulopathy Not Requiring Invasive Mechanical Ventilation

    Randomized, controlled study conducted in hospitalized patients with severe COViD-19 pneumonia and coagulopathy not requiring invasive mechanical ventilation. Aim of this study is to assess whether high doses of Low Molecular Weight Heparin (LMWH) (ie. Enoxaparin 70 IU/kg twice daily) compared to standard prophylactic dose (ie, Enoxaparin 4000 IU once day) are: 1. More effective to prevent clinical worsening, defined as the occurrence of at least one of the following events, whichever comes first, during hospital stay: 1. Death 2. Acute Myocardial Infarction [AMI] 3. Objectively confirmed, symptomatic arterial or venous thromboembolism [TE] 4. Need for either non-invasive - Continuous Positive Airway Pressure (Cpap) or Non-Invasive Ventilation (NIV) - or invasive mechanical ventilation for patients who are in standard oxygen therapy by delivery interfaces at randomisation 5. Need for invasive mechanical ventilation for patients who are in non-invasive mechanical ventilation at randomisation 2. Similar in terms of major bleeding risk during hospital stay

    NCT04408235
    Conditions
    1. COVID
    2. Pneumonia, Viral
    3. Coagulation Disorder
    Interventions
    1. Drug: Enoxaparin
    MeSH:Pneumonia, Viral Pneumonia Hemostatic Disorders Blood Coagulation Disorders
    HPO:Abnormality of coagulation Abnormality of the coagulation cascade Pneumonia

    Primary Outcomes

    Description: Death Acute Myocardial Infarction [AMI] Objectively confirmed, symptomatic arterial or venous thromboembolism [TE] Need for either non-invasive - Continuous Positive Airway Pressure (Cpap) or Non-Invasive Ventilation (NIV) - or invasive mechanical ventilation for patients, who are in standard oxygen therapy by delivery interfaces at randomisation Need for invasive mechanical ventilation for patients, who are in non-invasive mechanical ventilation at randomisation

    Measure: Clinical worsening, defined as the occurrence of at least one of the following events, whichever comes first:

    Time: through study completion, up to 30 days

    Secondary Outcomes

    Description: Death Acute Myocardial Infarction [AMI] Objectively confirmed, symptomatic arterial or venous thromboembolism [TE] Need for either non-invasive - Continuous Positive Airway Pressure (Cpap) or Non-Invasive Ventilation (NIV) - or invasive mechanical ventilation for patients, who are in standard oxygen therapy by delivery interfaces at randomisation Need for invasive mechanical ventilation for patients, who are in non-invasive mechanical ventilation at randomisation Improvement of laboratory parameters of disease severity, including: D-dimer level Plasma fibrinogen levels Mean Platelet Volume Lymphocyte/Neutrophil ratio IL-6 plasma levels

    Measure: Any of the following events occurring within the hospital stay

    Time: through study completion, up to 30 days

    Description: Information about patients' status will be sought in those who are discharged before 30 days on Day 30 from randomisation.

    Measure: Mortality at 30 days

    Time: 30 days
    7 Investigating the Relationship Between the Renin Angiotensin System and the Coagulopathy Associated With COVID-19

    To determine whether the coagulopathy associated with COVID-19 infection is driven by overactivation of the renin angiotensin system (RAS)

    NCT04419610
    Conditions
    1. COVID
    Interventions
    1. Biological: TRV027
    2. Other: sodium chloride 0.9%
    MeSH:Hemostatic Disorders Blood Coagulation Disorders
    HPO:Abnormality of coagulation Abnormality of the coagulation cascade

    Primary Outcomes

    Description: Mean change from baseline D-dimer at day 8 following administration of TRV027 or placebo.

    Measure: Coagulopathy associated with COVID-19

    Time: Day 1 and Day 8

    Secondary Outcomes

    Description: Absolute D-Dimer - (Fibrin Equivalent units)

    Measure: Markers of dysregulation of coagulation system

    Time: Day 1, 3, 5 and Day 8

    Description: platelet count (E9 /L)

    Measure: Markers of dysregulation of coagulation system

    Time: Day 1, 3, Day 5 and Day 8

    Description: aPTT (Activated Partial Thromboplastin time) - seconds

    Measure: Markers of dysregulation of coagulation system

    Time: Day 1, 3, Day 5 and Day 8

    Description: INR - (calculated as a ratio from aPTT)

    Measure: Markers of dysregulation of coagulation system

    Time: Day 1, 3, Day 5 and Day 8

    Description: fibrinogen (g/L)

    Measure: Markers of dysregulation of coagulation system

    Time: Day 1, 3, Day 5 and Day 8

    Description: Ferritin Ug/mL

    Measure: Markers of dysregulation of coagulation system

    Time: Day 1, 3, Day 5 and Day 8

    Description: Plasma Renin Mass and activity (nmol/L/h)

    Measure: Markers of dysregulation of RAS

    Time: Day 1

    Description: Total bilirubin (umol/L)

    Measure: Markers of Haemolysis/inflammation

    Time: Day 1, 3, Day 5 and Day 8

    Description: LDH u/L

    Measure: Markers of Haemolysis/Inflammation

    Time: Day 3, Day 5 and Day 8

    Description: Haptoglobin g/L

    Measure: Markers of Haemolysis/inflammation

    Time: Day 1, 3, Day 5 and Day 8

    Description: Pro-calcitonin ug/L

    Measure: Markers of Inflammation (bacterial sepsis)

    Time: day 1, 3, 5 and 8

    Description: Creatinine (umol/L)

    Measure: Markers of organ dysregulation - kidney

    Time: Day 1, 3, Day 5 and Day 8

    Description: BNP (B-type natriuetic Peptide) ng/L

    Measure: Markers of dysregulation of cardiovascular system

    Time: Day 1, 3, Day 5 and Day 8

    Description: Troponin ng/L

    Measure: Markers of dysregulation of cardiovascular system

    Time: Day 1, 3, Day 5 and Day 8

    Description: glucose mmol/L

    Measure: marker of dysregulation of endocrine system

    Time: Day 1, 3, Day 5 and Day 8
    8 The Utility of Camostat Mesylate in Patients With COVID-19 Associated Coagulopathy (CAC) and Cardiovascular Complications

    The primary aim of this study is to determine whether Camostat mesylate reduces SARS-COV-2 associated coagulopathy. Additional aims are to determine the effect of Camostat mesylate on SARS-COV-2 associated myocardial injury, to assess duration of hypoxia or intubation, to evaluate the length of intensive care unit and hospital stay, and assess mortality rates.

    NCT04435015
    Conditions
    1. Coagulopathy
    2. Cardiovascular Complication
    3. COVID-19
    Interventions
    1. Drug: Camostat Mesylate
    2. Drug: Microcrystalline Cellulose, NF
    MeSH:Hemostatic Disorders Blood Coagulation Disorders
    HPO:Abnormality of coagulation Abnormality of the coagulation cascade

    Primary Outcomes

    Description: The sum percent change in D-Dimer over 7 days will be compared to day 1

    Measure: Percent change in plasma D-Dimer

    Time: 7 days

    Secondary Outcomes

    Description: The first assessment on mortality and complications will be carried out 3 months after the start of the study.

    Measure: Overall Safety and adverse event

    Time: 3 months

    Description: Percent change in fibrinogen over 7 days compared to day 1

    Measure: Change in plasma Fibrinogen levels

    Time: 7 days

    Description: Percent change in troponin over 7 days compared to day 1

    Measure: Change in plasma troponin

    Time: 7 days

    Description: New onset cardiomyopathy defined by a reduction of EF by greater than 10% or less than 45% will be measured

    Measure: New onset cardiomyopathy

    Time: 7 days

    Description: Days with hypoxia (Room Air O2 Sat<93%) or days intubated

    Measure: Duration of intubation

    Time: 7 days

    Description: The number of days in the intensive care unit

    Measure: Length of stay in the intensive care unit

    Time: 28 days

    Description: The number of days since admission to discharge

    Measure: Time to discharge from hospital

    Time: 30 days

    Description: The ocurrence of major adverse cardiovascular events (MACE): MI, stroke, CHF, PCI, death from cardiovascular disease will be studied.

    Measure: Occurrence of major adverse cardiovascular events

    Time: 7 days
    9 Utilização da Enoxaparina em Dose Anticoagulante em Pacientes Hospitalizados Com síndrome respiratória Aguda Grave Por COVID-19

    Published papers evaluating coagulopathy on COVID-19 patients indicate a higher incidence of thromboembolic events, sometimes, as high as 20%. Such events increase ICU admissions and are associated with death. Considering the importance of thromboembolic events concurring to deteriorate clinical state, we propose to conduct a parallel pragmatic open-label randomized controlled trial to determine the effect of therapeutic anticoagulation compared to standard care in hospitalized patients with COVID-19 and with low oxygen saturation.

    NCT04444700
    Conditions
    1. COVID
    2. Coronavirus Infection
    3. Severe Acute Respiratory S
    4. Severe Acute Respiratory Syndrome
    5. Thromboembolism, Venous
    6. Anticoagulants and Bleeding Disorders
    Interventions
    1. Drug: Therapeutic anticoagulation
    MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Thromboembolism Hemostatic Disorders Venous Thromboembolism Blood Coagulation Disorders
    HPO:Abnormality of coagulation Abnormality of the coagulation cascade Thromboembolism

    Primary Outcomes

    Description: Composite outcome of ICU admission (yes/no), non-invasive positive pressure ventilation (yes/no), invasive mechanical ventilation (yes/no), or all-cause death (yes/no) up to 28 days.

    Measure: Composite main outcome

    Time: up to 28 days

    Secondary Outcomes

    Description: All-cause death

    Measure: All-cause death

    Time: 28 days

    Description: Composite outcome of ICU admission or all-cause death

    Measure: Composite outcome of ICU admission or all-cause death

    Time: 28 days

    Description: Major bleeding

    Measure: Major bleeding

    Time: 28 days

    Description: Red Blood Cell transfusion (greater than or equal to 1 unit)

    Measure: Number of participants who received red blood cell transfusion

    Time: 28 days

    Description: Transfusion of platelets, frozen plasma, prothrombin complex concentrate, cryoprecipitate and/or fibrinogen concentrate

    Measure: Number of participants with transfusion of platelets, frozen plasma, prothrombin complex concentrate, cryoprecipitate and/or fibrinogen concentrate.

    Time: 28 days

    Description: Hospital-free days alive up to day 28

    Measure: Number of hospital-free days alive up to day 28

    Time: 28 days

    Description: ICU-free days alive up to day 28

    Measure: Number of ICU-free days alive up to day 28

    Time: 28 days

    Description: Ventilator-free days alive up to day 28

    Measure: Number of ventilator-free days alive up to day 28

    Time: 28 days

    Description: Venous thromboembolism

    Measure: Number of participants with venous thromboembolism

    Time: 28 days

    Description: Arterial thromboembolism

    Measure: Number of participants with arterial thromboembolism

    Time: 28 days

    Description: Heparin induced thrombocytopenia

    Measure: Number of participants with heparin induced thrombocytopenia

    Time: 28 days
    10 Exploratory Assessment of the Coagulation Changes Associated With Severe Inflammation in COVID-19 Patients

    This study will study the potential utility of the Quantra QPlus System in patients inflicted with COVID-19 disease.

    NCT04460664
    Conditions
    1. COVID
    2. Disseminated Intravascular Coagulation
    3. Coagulation Disorder
    Interventions
    1. Diagnostic Test: Quantra System
    MeSH:Hemostatic Disorders Blood Coagulation Disorders Disseminated Intravascular Coagulation
    HPO:Abnormality of coagulation Abnormality of the coagulation cascade Disseminated intravascular coagulation

    Primary Outcomes

    Description: Coagulation function assessed by the Quantra

    Measure: Quantra Clot Time results

    Time: Within 24 hours of admission to the hospital

    Description: Coagulation function assessed by the Quantra

    Measure: Quantra Clot Time results

    Time: 48 to 72 hours after transfer to ICU

    Description: Coagulation function assessed by the Quantra

    Measure: Quantra Clot Time results

    Time: 1 to 24 hours prior to discharge from hospital

    Description: Coagulation function assessed by the Quantra

    Measure: Quantra Clot Stiffness results

    Time: Upon arrival at hospital

    Description: Coagulation function assessed by the Quantra

    Measure: Quantra Clot Stiffness results

    Time: 48 to 72 hours after transfer to ICU

    Description: Coagulation function assessed by the Quantra

    Measure: Quantra Clot Stiffness results

    Time: 1 to 24 hours prior to discharge from hospital
    11 Uppföljning av Patienter Som intensivvårdats för COVID-19

    The study will follow COVID-19 patients who required intensive care after 3-6 months and one year after discharge from the ICU with functional level as well as organ function to assess recovery after COVID-19. Blood and urine will be collected for biobanking.

    NCT04474249
    Conditions
    1. COVID19
    2. ARDS
    3. AKI
    4. Circulatory Failure
    5. Coagulation Disorder
    6. Inflammatory Response
    MeSH:Hemostatic Disorders Blood Coagulation Disorders Shock
    HPO:Abnormality of coagulation Abnormality of the coagulation cascade

    Primary Outcomes

    Description: Death

    Measure: Mortality

    Time: Within 90 days after admission to ICU.

    Description: Death

    Measure: Mortality

    Time: Within 1 year after admission to ICU.

    Description: Return of renal function measured as CKD stage.

    Measure: Renal recovery

    Time: At follow-up three to six months after ICU discharge.

    Description: Return of renal function measured as CKD stage.

    Measure: Renal recovery

    Time: At follow-up one year after ICU discharge.

    Description: Respiratory function as assessed by a clinician

    Measure: Respiratory recovery

    Time: Three to six months from discharge from ICU

    Description: 6 min walk test

    Measure: Working capacity

    Time: Three to six months from discharge from ICU

    Description: Quality of Life assessed using the 36-item short form survey by RAND.

    Measure: Quality of life score

    Time: Three to six months from discharge from ICU

    Description: Cognitive screening using the Montreal Cognitive Assessment.

    Measure: Cognitive recovery

    Time: Three to six months from discharge from ICU

    Description: Screening for frailty using the Clinical Frailty Scale-9.

    Measure: Frailty

    Time: Three to six months from discharge from ICU

    Description: Screening of functional level for Activities of Daily Life using the 5-level EQ-5D.

    Measure: Activities of Daily Life

    Time: Three to six months from discharge from ICU

    Description: Screening for anxiety using the Generalised Anxiety Disorder 7-item scale.

    Measure: Anxiety

    Time: Three to six months from discharge from ICU

    Description: Screening for depression using the Patient Health Questionnaire 9.

    Measure: Depression

    Time: Three to six months from discharge from ICU

    Description: Neurological function as assessed by a clinician

    Measure: Neurological recovery

    Time: Three to six months from discharge from ICU
    12 Evaluation of the Role of Sonoclot Signature in Assessment of Coagulopathy in Critically Ill COVID 19 Patients

    Novel coronavirus disease 19 (COVID-19) is caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), this pneumonia was first emerged in December 2019 in Wuhan, China and rapidly spread around the world . Coagulopathy is one of the most significant prognostic factors in patients with COVID-19 and is associated with increased mortality and admission to critical care. Most observed coagulopathy in patients hospitalized with COVID-19 (COVID-19-associated coagulopathy) is characterized by increased D-dimer and fibrinogen levels. 71% of patients who did not survive hospitalization reported to have developed disseminated intravascular coagulation

    NCT04479280
    Conditions
    1. Coagulation Disorder
    Interventions
    1. Device: Sonclot Coagulation and platelet function Analyzer SCP1, Sienco, USA
    MeSH:Hemostatic Disorders Blood Coagulation Disorders
    HPO:Abnormality of coagulation Abnormality of the coagulation cascade

    Primary Outcomes

    Description: measuring how rapid the sample will get clotted

    Measure: clot rate formation

    Time: 30 minutes
    13 Assessment of COVID-19 Associated Coagulopathy and Hypercoagulable State in Upper Egypt

    Coagulopathy is one of the most significant prognostic factors in patients with COVID-19 and is associated with increased mortality and admission to critical care. Most commonly observed coagulopathy in patients hospitalized with COVID-19 (COVID-19-associated coagulopathy) is characterized by increased D-dimer and fibrinogen levels. 71% of patients who did not survive hospitalization reported to have developed disseminated intravascular coagulation (DIC) compared to 0.6% of survivors.

    NCT04507230
    Conditions
    1. Coagulopathy
    MeSH:Hemostatic Disorders Blood Coagulation Disorders
    HPO:Abnormality of coagulation Abnormality of the coagulation cascade

    Primary Outcomes

    Description: Full coagulation screen

    Measure: Coagulation screen

    Time: 1 month

    Description: Full thrombophilia screen

    Measure: Thrombophilia screen

    Time: 1 month

    Description: VWFAg, FVIII

    Measure: VWF, FVIII

    Time: 1 month
    14 Effect of the Use of Anticoagulant Therapy During Hospitalization and Discharge in Patients With COVID-19 Infection

    Viral infections provoke the systemic inflammatory response and cause an imbalance between the procoagulant and anticoagulant homeostatic mechanisms. Multiple pathogenic mechanisms are involved, including endothelial dysfunction, increased von Willebrand factor, Toll receptor activation, and tissue factor pathway activation. D-dimer levels greater than 1000 ng / mL are associated with an 18-fold increased risk of mortality. In this context, many patients may require prophylaxis or antithrombotic treatment with low molecular weight heparins. Currently, there is no validated scheme on the dose and timing of the use of antithrombotic drugs. The study aims to identify the effect of two anticoagulant strategies (prophylactic and therapeutic) on the progression to ventilatory support or death in patients with COVID-19 infection who require hospital care.

    NCT04508439
    Conditions
    1. Covid19
    2. Pneumonia
    3. Coagulation Disorder
    4. Pulmonary Embolism
    Interventions
    1. Drug: Enoxaparin
    MeSH:Pneumonia Pulmonary Embolism Embolism Hemostatic Disorders Blood Coagulation Disorders
    HPO:Abnormality of coagulation Abnormality of the coagulation cascade Pneumonia Pulmonary embolism

    Primary Outcomes

    Description: Identify the benefit of different doses of low molecular weight heparin (enoxaparin) on ventilatory support time in patients requiring hospital care for COVID-19 infection.

    Measure: low molecular weight heparin (enoxaparin) and ventilatory support time

    Time: 30 days

    Description: To compare oral anticoagulation therapy by administering Rivaroxaban 10mg PO every 24 hours on early thrombotic complications

    Measure: thrombotic complications and Rivaroxaban

    Time: 30 days

    Description: Identify the benefit of different doses of low molecular weight heparin (enoxaparin) on the length of hospital stay in patients requiring hospital care for COVID-19 infection.

    Measure: low molecular weight heparin (enoxaparin) and length of hospital stay

    Time: 30 days

    Description: Identify the benefit of different doses of low molecular weight heparin (enoxaparin) over mortality rate in patients requiring hospital care for COVID-19 infection.

    Measure: low molecular weight heparin (enoxaparin) and mortality rate

    Time: 30 days
    15 Randomized, Prospective, Open-label, Controlled Parallel-group Trial Investigating the Efficacy of Therapeutic Plasma Exchange as an Adjunctive Strategy to Treat the Systemic Inflammatory Response Against SARS-CoV2 and the Associated Coagulopathy

    Randomized controlled trial to analyse adjuvant therapeutic plasma exchange (TPE) in severe Covid-19 associated coagulopathy and systemic inflammation compared to current standard of care (SOC). A total of three TPEs (d1, 3, 5) will be performed in the intervention group. Primary endpoint is the reversibility of relative ADAMTS13 deficiency (indicated by the change in ADAMTS13 / VWF:Ag ratio from day 1 to 7).

    NCT04613986
    Conditions
    1. Severe Covid-19
    Interventions
    1. Device: therapeutic plasmaexchnage
    MeSH:Hemostatic Disorders Blood Coagulation Disorders
    HPO:Abnormality of coagulation Abnormality of the coagulation cascade

    Primary Outcomes

    Description: ADAMTS13 / VWF:Ag

    Measure: relative ADAMTS13 deficiency

    Time: day 1 to 7

    HPO Nodes


    Reports

    Data processed on December 13, 2020.

    An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.

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