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

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ClinicalTrials.gov Identifier: NCT04356144
Recruitment Status : Recruiting
First Posted : April 22, 2020
Last Update Posted : May 5, 2020
Sponsor:
Collaborator:
Medical Scientific Fund of the Mayor of Vienna
Information provided by (Responsible Party):
Lukas Infanger, 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.

Condition or disease Intervention/treatment
Disseminated Intravascular Coagulation Critical Illness Sars-CoV2 Viral Infection Coagulation Disorder, Blood Covid19 Diagnostic Test: Thrombin Generation Assay (TGA) Diagnostic Test: Thrombomodulin Modified Thrombin Generation Assay (TGA-TM)

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Coagulation Assays in the Critically Ill Patient: a New Approach Using the Thrombomodulin-modified Thrombin Generation Assay (TGA-TM)
Actual Study Start Date : April 15, 2020
Estimated Primary Completion Date : October 1, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Critical infection
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)
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).

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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
60 critically ill patients with signs of infection with SARS-CoV2 or proven infection with SARS-CoV-2 admitted to Intensive Care Units (ICU).
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04356144


Contacts
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Contact: Lukas Infanger, MD +43140400 ext 41070 lukas.infanger@meduniwien.ac.at
Contact: Marion Wiegele, MD +43140400 ext 41070 marion.wiegele@meduniwien.ac.at

Locations
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Austria
Medical University Vienna Recruiting
Vienna, Austria, 1090
Contact: Lukas Infanger, MD    +43140400 ext 41070    lukas.infanger@meduniwien.ac.at   
Sponsors and Collaborators
Medical University of Vienna
Medical Scientific Fund of the Mayor of Vienna
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Responsible Party: Lukas Infanger, Principal Investigator, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT04356144    
Other Study ID Numbers: TGA-TM-Critical-2019
First Posted: April 22, 2020    Key Record Dates
Last Update Posted: May 5, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lukas Infanger, Medical University of Vienna:
TGA
thrombin generation
Sars-CoV2
ROTEM
rotational thromboelastometry
viscoelastic assay
thrombomodulin
Additional relevant MeSH terms:
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Infection
Virus Diseases
Hemostatic Disorders
Blood Coagulation Disorders
Disseminated Intravascular Coagulation
Critical Illness
Disease Attributes
Pathologic Processes
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders
Thrombophilia
Thrombin
Hemostatics
Coagulants