Clinical trial NCT04356144: Thrombomodulin-modified Thrombin Generation Assay (TGA-TM) in Patients With Critical Infections
Official title: Coagulation Assays in the Critically Ill Patient: a New Approach Using the Thrombomodulin-modified Thrombin Generation Assay (TGA-TM)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Disseminated Intravascular Coagulation
Critical Illness
Sars-CoV2
Viral Infection
Coagulation Disorder, Blood
Covid19
Keywords: TGA
thrombin generation
Sars-CoV2
ROTEM
rotational thromboelastometry
viscoelastic assay
thrombomodulin
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
Collaborators: name: Medical Scientific Fund of the Mayor of Vienna
First posted: 2020-04-22
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.


Eligibility 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

Primary outcomes:
measure: ETP (AUC) without rhThrombomodulin (rhTM)
timeFrame: 6 months
measure: ETP (AUC) with rhThrombomodulin (rhTM)
timeFrame: 6 months
measure: ETP-ratio
timeFrame: 6 months
measure: ETP-Normalisation
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University Vienna
Study officials:
References: