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

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

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

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

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

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

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

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

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

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

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

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

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

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

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