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

Completed

• Conditions: Sars-CoV2; Viral Infection; Covid19; Critical Illness; Disseminated Intravascular Coagulation; Coagulation Disorder, Blood
• Interventions: Diagnostic Test: Thrombin Generation Assay (TGA); Diagnostic Test: Thrombomodulin Modified Thrombin Generation Assay (TGA-TM)

• Registration Number: NCT04356144
• Lead Sponsor: Medical University of Vienna

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-15
• Study First Submitted: 2020-04-15
• Study First Submitted QC: 2020-04-18
• Study First Posted: 2020-04-22
• Primary Completion: 2021-02-01
• Study Completion: 2021-02-01
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-22
• Last Update Posted: 2021-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Critical infection	Thrombin Generation Assay (TGA)	Patients with signs of infection with SARS-CoV-2 or already diagnosed infection with SARS-CoV-2 admitted to the ICU
Critical infection	Thrombomodulin Modified Thrombin Generation Assay (TGA-TM)	Patients with signs of infection with SARS-CoV-2 or already diagnosed infection with SARS-CoV-2 admitted to the ICU

Primary Outcome Measures

Name	Time	Method
ETP (AUC) without rhThrombomodulin (rhTM)	6 months	nM;
ETP (AUC) with rhThrombomodulin (rhTM)	6 months	nM;
ETP-ratio	6 months	Ratio of endogenous thrombin potential (ETP) with rhTM to ETP without rhTM
ETP-Normalisation	6 months	Comparison of ETP-ratios from ICU patients and ETP-ratios from citrated plasma samples from healthy donors

Trial Locations

Locations (1)

Medical University Vienna; 🇦🇹 Vienna, Austria