Coagulation Disorder Clinical Trial
— ROTCLOTOfficial title:
Comparison of Viscoelastic Measurement by ROTEM® Delta and ClotPro® in Trauma Patients. Prospective Observational Study.
The purpose of the study is to describe the differences in measurements of viscoelastic tests of coagulation by two different devices in adult trauma patients.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | December 1, 2023 |
Est. primary completion date | December 1, 2023 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - age =18 years - polytrauma with Injury severity score = 16 Exclusion Criteria: - pregnancy - anticoagulant therapy - antiplatelet therapy - coagulation disorders |
Country | Name | City | State |
---|---|---|---|
Czechia | University Hospital Brno and Masaryk University Brno | Brno |
Lead Sponsor | Collaborator |
---|---|
Masaryk University | Brno University Hospital |
Czechia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clotting time (CT) in EX-test and EXTEM | difference in clotting time measured by EX-test and EXTEM | through study completion, an average of 3 months | |
Primary | Clot formation time (CFT) in EX-test and EXTEM | difference in clot formation time measured by EX-test and EXTEM | through study completion, an average of 3 months | |
Primary | alfa angle in EX-test and EXTEM | difference in alfa angle measured by EX-test and EXTEM | through study completion, an average of 3 months | |
Primary | maximum clot firmness (MCF) in EX-test and EXTEM | difference in maximum clot firmness measured by EX-test and EXTEM | through study completion, an average of 3 months | |
Primary | maximum lysis (ML) in EX-test and EXTEM | maximum lysis difference in MCF measured by EX-test and EXTEM | through study completion, an average of 3 months | |
Primary | clotting time (CT) FIB-test and FIBTEM | difference in clotting time measured by FIB-test and FIBTEM | through study completion, an average of 3 months | |
Primary | clot formation time (CFT) FIB-test and FIBTEM | difference in clot formation time measured by FIB-test and FIBTEM | through study completion, an average of 3 months | |
Primary | maximum clot firmness (MCF) FIB-test and FIBTEM | difference in maximum clot firmness measured by FIB-test and FIBTEM | through study completion, an average of 3 months | |
Primary | alfa angle FIB-test and FIBTEM | difference in alfa angle measured by FIB-test and FIBTEM | through study completion, an average of 3 months | |
Primary | maximum lysis (ML) FIB-test and FIBTEM | difference in maximum lysis measured by FIB-test and FIBTEM | through study completion, an average of 3 months | |
Secondary | patient temperature | effect of patients´ temperature on results of measurements | through study completion, an average of 3 months | |
Secondary | maximum clot firmness (MCF) FIB-test and Clauss method | correlation of maximum clot firmness with blod fibrinogen level | through study completion, an average of 3 months | |
Secondary | maximum clot firmness (MCF) FIBTEM and Clauss method | correlation of maximum clot firmness with blod fibrinogen level | through study completion, an average of 3 months |
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