Analysis of the Coagulopathy Developed by COVID-19 Infected Patients

NCT04356950 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 175

Last updated 2025-12-04

No results posted yet for this study

Summary

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.

Conditions

  • Sepsis
  • Blood Coagulation Disorders
  • Thrombin
  • Disseminated Intravascular Coagulation
  • COVID-19

Interventions

OTHER

Thrombin generation test assay

lag time, initial velocity, time-to-peak, thrombin peak, total thrombin generation time, extrinsic thrombin potential (ETP). Crude quantitative values and relative values (%, by reference to the one obtained with an invariant reference plasma). Both without the addition of purified thrombomodulin (TM-) and with the addition of purified thrombomodulin (TM+). The ability of TM to inhibit thrombin generation will be calculated as follows: \[ETP (%)(TM+) / ETP (%)(TM-)\].

OTHER

Fibrin generation markers assays

D-dimers (coagulation plus fibrinolysis), soluble fibrin monomers (coagulation only)

Sponsors & Collaborators

  • Centre Hospitalier Universitaire de Nīmes

    lead OTHER

Principal Investigators

  • Jean-Christophe Gris · CHU Nimes

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-28
Primary Completion
2022-02-14
Completion
2022-02-14

Countries

  • France

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04356950 on ClinicalTrials.gov