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Clinical Trials/NCT04356144
NCT04356144
Completed
Not Applicable

Coagulation Assays in the Critically Ill Patient: a New Approach Using the Thrombomodulin-modified Thrombin Generation Assay (TGA-TM)

Medical University of Vienna1 site in 1 country58 target enrollmentApril 15, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Disseminated Intravascular Coagulation
Sponsor
Medical University of Vienna
Enrollment
58
Locations
1
Primary Endpoint
ETP (AUC) without rhThrombomodulin (rhTM)
Status
Completed
Last Updated
5 years ago

Overview

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 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.

Registry
clinicaltrials.gov
Start Date
April 15, 2020
End Date
February 1, 2021
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Lukas Infanger

Principal Investigator

Medical University of Vienna

Eligibility Criteria

Inclusion Criteria

  • 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 Criteria

  • 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

Outcomes

Primary Outcomes

ETP (AUC) without rhThrombomodulin (rhTM)

Time Frame: 6 months

nM;

ETP (AUC) with rhThrombomodulin (rhTM)

Time Frame: 6 months

nM;

ETP-ratio

Time Frame: 6 months

Ratio of endogenous thrombin potential (ETP) with rhTM to ETP without rhTM

ETP-Normalisation

Time Frame: 6 months

Comparison of ETP-ratios from ICU patients and ETP-ratios from citrated plasma samples from healthy donors

Study Sites (1)

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