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