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Completed

NCT Number: NCT04356144

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

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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Key information

Conditions

Disseminated Intravascular Coagulation Blood Coagulation Disorders COVID-19 Coagulation Disorder, Blood Coronaviridae Infections Coronavirus Infections Covid19 Critical Illness Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Infections Lung Diseases Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Sars-CoV2 Thrombophilia Viral Infection Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University Vienna

Vienna, 1090, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

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.

Primary outcomes

  1. ETP (AUC) without rhThrombomodulin (rhTM)

    Time frame: 6 months

    nM;

  2. ETP (AUC) with rhThrombomodulin (rhTM)

    Time frame: 6 months

    nM;

  3. ETP-ratio

    Time frame: 6 months

    Ratio of endogenous thrombin potential (ETP) with rhTM to ETP without rhTM

  4. ETP-Normalisation

    Time frame: 6 months

    Comparison of ETP-ratios from ICU patients and ETP-ratios from citrated plasma samples from healthy donors

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Collaborators

  • Medical Scientific Fund of the Mayor of Vienna

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 22, 2020
Registry last updated
Mar 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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