U07.1 U07.2
Conditions
Interventions
Group 1: Observational Study.
Study population and inclusion criteria: 250 adult (= 18 years) CORVID-19 patients with the need for in-hospital treatment. In hospitalized COVID-19 patients, ICU admis
further 5 ml blood might be necessary for standard coagulation tests, differential blood count and other lab analysis if not already done as routine).
ROTEM sigma device: ROTEM sigma is a closed, ca
Sponsors
Tem Innovations
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: Suspected or proven COVID-19
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Prediction of the need for intensive care, endotracheal intubation and mechanical ventilation, extracorporeal membran oxygenation (ECMO), hospital discharge or death | — |
Secondary
| Measure | Time frame |
|---|---|
| Development of a COVID-19 score | — |
Countries
Brazil, Colombia, Germany, India, Italy, Mexico, Portugal, Qatar, Saudi Arabia, Spain
Contacts
Public ContactKlaus Görlinger
Tem Innovations
Outcome results
None listed