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

Medical University of Vienna

Status: Completed

Conditions: Sars-CoV2; Critical Illness; Disseminated Intravascular Coagulation; Covid19; Viral Infection; Coagulation Disorder, Blood

Treatments: Diagnostic Test: Thrombin Generation Assay (TGA); Diagnostic Test: Thrombomodulin Modified Thrombin Generation Assay (TGA-TM)

Study type: Observational

Funder types: Other

Identifiers

NCT04356144

TGA-TM-Critical-2019

Details and patient eligibility

About

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.

Enrollment: 58 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

58 participants in 1 patient group

Critical infection

Description:

Patients with signs of infection with SARS-CoV-2 or already diagnosed infection with SARS-CoV-2 admitted to the ICU

Treatment:

Diagnostic Test: Thrombomodulin Modified Thrombin Generation Assay (TGA-TM)

Diagnostic Test: Thrombin Generation Assay (TGA)