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Thrombomodulin-modified Thrombin Generation Assay (TGA-TM) in Patients With Critical Infections

NCT04356144 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 58

Last updated 2021-03-23

No results posted yet for this study

Summary

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.

Conditions

  • Disseminated Intravascular Coagulation
  • Critical Illness
  • Sars-CoV2
  • Viral Infection
  • Coagulation Disorder, Blood
  • Covid19

Interventions

DIAGNOSTIC_TEST

Thrombin Generation Assay (TGA)

TGA via a fluorimetric module. Coagulation cascade is activated upon addition of different concentrations of tissue factor and phospholipids. The fluorogenic substrate Z-Gly-Gly-Arg-AMC (ZGGR-AMC) is cleaved by formed thrombin over time. By plotting the changes in fluorescence as a function of time (cnt/min), it depicts the "Thrombin Generation Curve" (thrombin generated - plotted against time). The area under the thrombin curve is defined as the endogenous thrombin potential (ETP).

DIAGNOSTIC_TEST

Thrombomodulin Modified Thrombin Generation Assay (TGA-TM)

Recombinant Human Thrombomodulin (TM) is added to the conventional TGA. When recombinant TM is added, the protein C system is fully activated and therefore the ETP obtained reflects both the anti- and procoagulant factors.

Sponsors & Collaborators

  • Medical Scientific Fund of the Mayor of Vienna

    collaborator OTHER

  • Medical University of Vienna

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-15
Primary Completion
2021-02-01
Completion
2021-02-01

Countries

  • Austria

Study Locations

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Entities

Diseases

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 NCT04356144 on ClinicalTrials.gov