There are 3 clinical trials

Clinical Trials

1 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 Disseminated Intravascular Coagulation Critical Illness Sars-CoV2 Viral Infection Coagulation Disorder, Blood Covid19 Diagnostic Test: Thrombin Generation Assay (TGA) Diagnostic Test: Thrombomodulin Modified Thrombin Generation Assay (TGA-TM)

MeSH:Infection Hemostatic Disorders Blood Coagulation Disorders Disseminated Intravascular Coagulation Critical Illness Virus Diseases

HPO:Abnormality of coagulation Abnormality of the coagulation cascade Disseminated intravascular coagulation

2 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 Sepsis Blood Coagulation Disorders Thrombin Disseminated Intravascular Coagulation COVID-19 Other: Thrombin generation test assay 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

3 The LEAD COVID-19 Trial: Low-risk, Early Aspirin and Vitamin D to Reduce COVID-19 Hospitalizations

Although the novel SARS-CoV-2 virus (COVD-19) is classified as an acute respiratory infection, emerging data show that morbidity and mortality are driven by disseminated intravascular coagulopathy. Untreated CAC leads to microangiopathic thromboses, causing multiple systems organ failure and consuming enormous healthcare resources. Identifying strategies to prevent CAC are therefore crucial to reducing COVID-19 hospitalization rates. The pathogenesis of CAC is unknown, but there are major overlaps between severe COVID-19 and vitamin D insufficiency (VDI). We hypothesize that VDI is a major underlying contributor to CAC. Preliminary data from severe COVID-19 patients in New Orleans support this hypothesis. The purpose of the proposed multi-center, prospective, randomized controlled trial is to test the hypothesis that low-risk, early treatment with aspirin and vitamin D in COVID-19 can mitigate the prothrombotic state and reduce hospitalization rates.

NCT04363840 COVID Vitamin D Deficiency Coagulopathy Disseminated Intravascular Coagulation Drug: Aspirin 81 mg Dietary Supplement: Vitamin D

MeSH:Disseminated Intravascular Coagulation Vitamin D Deficiency

HPO:Disseminated intravascular coagulation Low levels of vitamin D

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