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D020141: Hemostatic Disorders

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 (34)


Name (Synonyms) Correlation
drug594 COVID-19 Wiki 0.35
drug3291 Symptoms questionnare Wiki 0.26
drug3414 Thrombin Generation Assay (TGA) Wiki 0.26
Name (Synonyms) Correlation
drug608 COVID-19 PCR and Serology Wiki 0.26
drug605 COVID-19 IgG/IgM Rapid Test Cassette test (Healgen Scientific, Houston, Texas, USA) Wiki 0.26
drug1688 Intermediate dose thromboprophylaxis Wiki 0.26
drug598 COVID-19 Breastfeeding Support Wiki 0.26
drug353 Açaí palm berry extract - natural product Wiki 0.26
drug595 COVID-19 Androgen Sensitivity Test (CoVAST) Wiki 0.26
drug3654 Wearable Medical Device (Empatica E4) Wiki 0.26
drug3317 TRV027 Wiki 0.26
drug2038 Microcrystalline Cellulose, NF Wiki 0.26
drug1307 Fibrin generation markers assays Wiki 0.26
drug3415 Thrombin generation test assay Wiki 0.26
drug3416 Thrombomodulin Modified Thrombin Generation Assay (TGA-TM) Wiki 0.26
drug3387 Therapeutic Anticoagulation Wiki 0.26
drug607 COVID-19 PCR Swab Wiki 0.26
drug2702 Pulse Oximeter Wiki 0.26
drug603 COVID-19 FACILITY Wiki 0.26
drug3375 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
drug3141 Sonclot Coagulation and platelet function Analyzer SCP1, Sienco, USA Wiki 0.26
drug3198 Standard of Care thromboprophylaxis Wiki 0.26
drug4111 therapeutic plasmaexchnage Wiki 0.26
drug2722 Quantra System Wiki 0.26
drug609 COVID-19 PCR and serology testing Wiki 0.26
drug4079 sodium chloride 0.9% Wiki 0.26
drug596 COVID-19 Antibody testing Wiki 0.26
drug599 COVID-19 Convalescent Plasma Wiki 0.23
drug3392 Therapeutic anticoagulation Wiki 0.18
drug613 COVID-19 Serology Wiki 0.18
drug687 Camostat Mesylate Wiki 0.18
drug612 COVID-19 RT-PCR Wiki 0.15
drug1193 Enoxaparin Wiki 0.13
drug2490 Placebo Wiki 0.01

Correlated MeSH Terms (29)


Name (Synonyms) Correlation
D001778 Blood Coagulation Disorders NIH 1.00
D004211 Disseminated Intravascular Coagulation NIH 0.35
D009080 Mucocutaneous Lymph Node Syndrome NIH 0.26
Name (Synonyms) Correlation
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 (12)


Name (Synonyms) Correlation
HP:0001928 Abnormality of coagulation HPO 1.00
HP:0005521 Disseminated intravascular coagulation HPO 0.35
HP:0002905 Hyperphosphatemia HPO 0.26
Name (Synonyms) Correlation
HP:0002900 Hypokalemia HPO 0.26
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


HPO

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Reports

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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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