An observational study in Disseminated Intravascular Coagulation, Critical Illness and Sars-CoV2, sponsored by Medical University of Vienna. Completed at 1 site in Austria. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-03-23.
Sponsored by Medical University of Vienna · Observational
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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 58 is below the median of 240 across 2,136 observational studies indexed under Infections.
Browse Infections studies →Medical University of Vienna is the lead sponsor of 1,076 studies on the registry; 177 are open to participants now.
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60 critically ill patients with signs of infection with SARS-CoV2 or proven infection with SARS-CoV-2 admitted to Intensive Care Units (ICU).
Exclusion Criteria:
Patients with signs of infection with SARS-CoV-2 or already diagnosed infection with SARS-CoV-2 admitted to the ICU
Diagnostic Test: Thrombin Generation Assay (TGA) · Diagnostic Test: Thrombomodulin Modified Thrombin Generation Assay (TGA-TM)
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).
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.
ETP (AUC) without rhThrombomodulin (rhTM)
nM;
Time frame: 6 months
ETP (AUC) with rhThrombomodulin (rhTM)
nM;
Time frame: 6 months
ETP-ratio
Ratio of endogenous thrombin potential (ETP) with rhTM to ETP without rhTM
Time frame: 6 months
ETP-Normalisation
Comparison of ETP-ratios from ICU patients and ETP-ratios from citrated plasma samples from healthy donors
Time frame: 6 months
Plan to share: Undecided
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This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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Medical University of Vienna