COVID-19 Clinical Trial
— COVID-TGTOfficial title:
Analysis of the Coagulopathy Developed by COVID-19 Infected Patients: Thrombin Generation Potential in COVID-19 Infected Patients
Verified date | September 2022 |
Source | Centre Hospitalier Universitaire de Nimes |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 175 |
Est. completion date | June 2, 2022 |
Est. primary completion date | February 14, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patient with SARS-CoV-2 infection entering hospitalization with or without resuscitation - The patient (or their carer) must have given their free and informed consent and signed the consent form - The patient must be a member or beneficiary of a health insurance plan Exclusion Criteria: - Pregnant or breastfeeding patient - It is impossible to give the subject informed information - The patient is under safeguard of justice or state guardianship - Thrombotic events during treatment: flare-up of venous thromboembolism, flare-up of atherothrombosis. - Long-term anticoagulant treatment (anti-vitamin K, direct oral anticoagulant). - Chronic anti-aggregation treatment. - Pre-existing constitutive or acquired known coagulation pathology: hemorrhagic diseases (thrombocytopenia, thrombocytopathy, hemophilia, von Willebrand's disease, hemorrhagiparous factor deficiency), and for thrombophilia (deficits in antithrombin, protein C or S , Factor V Leiden or Prothrombin 20201A mutation). |
Country | Name | City | State |
---|---|---|---|
France | CHU de Bordeaux | Bordeaux | |
France | CHU de Limoges | Limoges | |
France | CHU de Montpellier | Montpellier | |
France | CHU de Nimes | Nîmes |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire de Nimes |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 28-day survival rate | Death yes/no during hopstilization, 28 days after admittence | 1 month | |
Primary | Absolute thrombin generation test latent period | Seconds; without (TM-) and with (TM+) purified thrombomodulin | Day 0 | |
Primary | Relative thrombin generation test latent period compared to reference plasma | %; without (TM-) and with (TM+) purified thrombomodulin | Day 0 | |
Primary | Absolute thrombin generation test initial velocity | nmol/s; without (TM-) and with (TM+) purified thrombomodulin | Day 0 | |
Primary | Relative thrombin generation test initial velocity compared to reference plasma | %; without (TM-) and with (TM+) purified thrombomodulin | Day 0 | |
Primary | Relative thrombin generation test peak thrombin compared to reference plasma | %; without (TM-) and with (TM+) purified thrombomodulin | Day 0 | |
Primary | Absolute thrombin generation test peak thrombin | nmol/L; without (TM-) and with (TM+) purified thrombomodulin | Day 0 | |
Primary | Absolute thrombin generation test peak thrombin time | Seconds; without (TM-) and with (TM+) purified thrombomodulin | Day 0 | |
Primary | Relative thrombin generation test peak thrombin time compared to reference plasma | %; without (TM-) and with (TM+) purified thrombomodulin | Day 0 | |
Primary | Absolute thrombin generation test total thrombin generation time | seconds; without (TM-) and with (TM+) purified thrombomodulin | Day 0 | |
Primary | Relative thrombin generation test total thrombin generation time compared to reference plasma | %; without (TM-) and with (TM+) purified thrombomodulin | Day 0 | |
Primary | Absolute thrombin generation test endogenous thrombin potential | Seconds; without (TM-) and with (TM+) purified thrombomodulin | Day 0 | |
Primary | Relative thrombin generation test endogenous thrombin potential compared to reference plasma | %; without (TM-) and with (TM+) purified thrombomodulin | Day 0 | |
Secondary | 3-month survival rate | Death yes/no | 3 months | |
Secondary | Transfer to intensive care unit during hospitalization | Yes/no | 3 months | |
Secondary | Thrombotic complication during hospitalization | Yes/no (deep vein thrombosis, pulmonary embolism, atherothrombosis flare, arterial thrombosis) | 3 months | |
Secondary | Plasma concentrations of D-dimers | µg / L, assayed by automated enzyme linked fluorescent assay (Vidas® D-dimers Exclusion ™ II) | Day 0 | |
Secondary | Plasma concentrations of soluble fibrin monomers | mg / L, measured by automated immunoagglutination (STA®-Liatest® FM) | Day 0 |
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