Status:

COMPLETED

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

Lead Sponsor:

Medical University of Vienna

Collaborating Sponsors:

Medical Scientific Fund of the Mayor of Vienna

Conditions:

Disseminated Intravascular Coagulation

Critical Illness

Eligibility:

All Genders

18+ years

Brief 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 bee...

Eligibility Criteria

Inclusion

  • Admission to ICU
  • Clinical signs of infection with SARS-CoV-2 or already diagnosed infection with SARS-CoV-2
  • Neutrophil-Lymphocyte Ratio (NLR) \>3

Exclusion

  • Intake of oral anticoagulants or any kind of parenteral therapeutic anticoagulation prior to ICU admission
  • Congenital coagulation disorder
  • Treatment with Prothrombin complex concentrate (F. II, VII, IX, X) or activated Prothrombin complex within past 48 hours
  • Treatment with recombinant factor VIIa (e.g. eptacog alfa) within past 48 hours
  • Treatment with recombinant protein C within past 48 hours
  • Active bleeding
  • Acute myocardial infarction
  • HIV infection
  • Chronic pancreatitis
  • Liver cirrhosis

Key Trial Info

Start Date :

April 15 2020

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

February 1 2021

Estimated Enrollment :

58 Patients enrolled

Trial Details

Trial ID

NCT04356144

Start Date

April 15 2020

End Date

February 1 2021

Last Update

March 23 2021

Active Locations (1)

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Medical University Vienna

Vienna, Austria, 1090