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TEM-tPAWiki

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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


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D013927 Thrombosis NIH 0.23

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There is one clinical trial.

Clinical Trials


1 Evaluation of TEM-tPA (Thromboelastometry With tPA) to Detect Covid-19 Patients at High Risk of Thrombosis

The coronavirus disease of 2019 (COVID-19) is a viral illness caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV2), now deemed a pandemic by the World Health Organization. Some COVID-19 patients may develop coagulopathy which is associated with poor prognosis and high risk of thrombosis. Some patients develop severe thrombotic complications, such as pulmonary embolism, despite anti-thrombotic prophylaxis by low molecular weight heparin. The aim of this project is to evaluate modified thromboelastometry for identifying patients at high risk of thrombosis. The hypothesize is that hypofibrinolysis with increased plasma PAI-1, TAFI (thrombin-activatable fibrinolysis inhibitor ) levels in association with high thrombin generation may explain high incidence of thrombosis in this population. A simple laboratory assay, widely available in hospitals, such as thromboelastometry, might be of great clinical interest to detect Covid-19 patients with high risk of thrombosis. In order to make ROTEM more sensitive to hypofibrinolysis, exogenous t-PA will be added in the assay. The preliminary results showed that patients with Covid-19 have significant hypercoagulability detectable with ROTEM and Covid-19 patients with thrombosis have both hypercoagulability and hypofibrinolysis.

NCT04366778 Thrombosis Covid-19 SARS-CoV 2 Diagnostic Test: TEM-tPA
MeSH:Thrombosis

Primary Outcomes

Description: TEM-tPA profile of patients will be defined with a combination of the following parameters : Maximal Clot Firmness (MCF) (mm) alpha angle (°) Lysis Index (LI) 30 (%) Lysis Onset Time (LOT) (min)

Measure: Coagulability

Time: Day 0

Description: TEM-tPA profile of patients will be defined with a combination of the following parameters : Maximal Clot Firmness (MCF) (mm) alpha angle (°) Lysis Index (LI) 30 (%) Lysis Onset Time (LOT) (min)

Measure: Coagulability

Time: Day 3

Description: TEM-tPA profile of patients will be defined with a combination of the following parameters : Maximal Clot Firmness (MCF) (mm) alpha angle (°) Lysis Index (LI) 30 (%) Lysis Onset Time (LOT) (min)

Measure: Coagulability

Time: Day 6

Description: TEM-tPA profile of patients will be defined with a combination of the following parameters : Maximal Clot Firmness (MCF) (mm) alpha angle (°) Lysis Index (LI) 30 (%) Lysis Onset Time (LOT) (min)

Measure: Coagulability

Time: Day 9

Description: TEM-tPA profile of patients will be defined with a combination of the following parameters : Maximal Clot Firmness (MCF) (mm) alpha angle (°) Lysis Index (LI) 30 (%) Lysis Onset Time (LOT) (min)

Measure: Coagulability

Time: Day 12

Description: TEM-tPA profile of patients will be defined with a combination of the following parameters : Maximal Clot Firmness (MCF) (mm) alpha angle (°) Lysis Index (LI) 30 (%) Lysis Onset Time (LOT) (min)

Measure: Coagulability

Time: Day 15

Description: Occurence of VTE or arterial thrombosis during hospitalization : Pulmonary embolism diagnosed with CT scan Venous or arterial thrombosis diagnosed with ultrasound exam

Measure: Venous thrombotic event (VTE) or arterial thrombosis

Time: Day 15


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