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| Name | Class |
|---|---|
| Medical Scientific Fund of the Mayor of Vienna | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Critical infection | Patients with signs of infection with SARS-CoV-2 or already diagnosed infection with SARS-CoV-2 admitted to the ICU |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thrombin Generation Assay (TGA) | Diagnostic Test | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| ETP (AUC) without rhThrombomodulin (rhTM) | nM; | 6 months |
| ETP (AUC) with rhThrombomodulin (rhTM) | nM; | 6 months |
| ETP-ratio | Ratio of endogenous thrombin potential (ETP) with rhTM to ETP without rhTM | 6 months |
| ETP-Normalisation | Comparison of ETP-ratios from ICU patients and ETP-ratios from citrated plasma samples from healthy donors | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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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).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University Vienna | Vienna | 1090 | Austria |
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|
| Thrombomodulin Modified Thrombin Generation Assay (TGA-TM) | Diagnostic Test | 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. |
|
| ID | Term |
|---|---|
| D004211 | Disseminated Intravascular Coagulation |
| D016638 | Critical Illness |
| D014777 | Virus Diseases |
| D001778 | Blood Coagulation Disorders |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D019851 | Thrombophilia |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007239 | Infections |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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