Predictive Value of ROTEM Analysis and Standard Coagulation Tests in Hospitalized Patients with COVID-19
- Conditions
- U07.1U07.2COVID-19, virus identifiedCOVID-19, virus not identified
- Registration Number
- DRKS00023934
- Lead Sponsor
- Tem Innovations
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 701
Suspected or proven COVID-19
Patients transferred from other hospitals, patients already intubated at hospital admission, and patients who in general decline ICU therapy verbally or in their patient’s provision; patients with no or negative COVID-19 testing. Patients which were assumed to be COVID-19-positive and first blood sample has been analyzed but COVID-19 testing showed negative results will be excluded from data analysis. Data from finally COVID-19-negative patients may be analyzed separately if the number of COVID-19-negative patients allow for a reasonable statistical analysis. Patients with no blood sample for ROTEM analysis within 24 hours after hospital admission will be excluded from data analysis since this blood sample is essential to predict course and outcome. Patients with missing mandatory data will be excluded from data analysis. Patients requiring ICU admission, intubation or ventilator therapy but this option is not available have to be exclude from patient’s outcome data analysis (hospital discharge vs death). Both, intended and performed treatment has to be documented. If a hospital doesn’t offer ECMO therapy is not an exclusion criterion for the study site but this has to be documented and mentioned in the methods section.
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Prediction of the need for intensive care, endotracheal intubation and mechanical ventilation, extracorporeal membran oxygenation (ECMO), hospital discharge or death
- Secondary Outcome Measures
Name Time Method Development of a COVID-19 score