Coagulation Disorder, Polytrauma
Conditions
Keywords
polytrauma, coagulopathy, viscoelastic tests
Brief summary
The purpose of the study is to describe the differences and interchangeability in measurements of viscoelastic tests of coagulation by two different devices in adult trauma patients.
Detailed description
The study will commence following the Approval by The Ethics Research Committee. All patients admitted to our emergency department for trauma from the 1st of October 2019 to the 31st of January 2020 will be enrolled after fulfilling the inclusion criteria and in the absence of any exclusion criteria. Informed consent will be requested. Viscoelastic tests of coagulation will be performed on ROTEM® Delta and ClotPro® simultaneously. We will compare values of clotting time (CT), clot formation time (CFT), alfa angle, maximum clot firmness (MCF) and maximum lysis (ML) for test of extrinsic pathway(EX-test) on ClotPro® vs. test for extrinsic pathway (EXTEM) on ROTEM® Delta. Further we will compare values of clotting time (CT), clot formation time (CFT), alfa angle, maximum clot firmness (MCF) and maximum lysis (ML) for thromboelastometry of fibrinogen (FIB-test) on ClotPro® vs. thromboelastometry of fibrinogen (FIBTEM) on ROTEM® Delta. The secondary outcome will be to describe the dependence of measurement on temperature of patient. Study data will be entered in study form. The measurements can be repeated in time. The indication for next measurement is fully on treating physician. Differences in estimated viscoelastic coagulation parameters and interchangeability of two devices will be analysed.
Interventions
None listed
Sponsors
Brno University Hospital
Masaryk University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* age ≥18 years * polytrauma with Injury severity score ≥ 16
Exclusion criteria
* pregnancy * anticoagulant therapy * antiplatelet therapy * coagulation disorders
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| maximum lysis (ML) FIB-test and FIBTEM | through study completion, an average of 3 months | difference in maximum lysis measured by FIB-test and FIBTEM |
| clot formation time (CFT) FIB-test and FIBTEM | through study completion, an average of 3 months | difference in clot formation time measured by FIB-test and FIBTEM |
| maximum clot firmness (MCF) FIB-test and FIBTEM | through study completion, an average of 3 months | difference in maximum clot firmness measured by FIB-test and FIBTEM |
| alfa angle FIB-test and FIBTEM | through study completion, an average of 3 months | difference in alfa angle measured by FIB-test and FIBTEM |
| Clotting time (CT) in EX-test and EXTEM | through study completion, an average of 3 months | difference in clotting time measured by EX-test and EXTEM |
| Clot formation time (CFT) in EX-test and EXTEM | through study completion, an average of 3 months | difference in clot formation time measured by EX-test and EXTEM |
| alfa angle in EX-test and EXTEM | through study completion, an average of 3 months | difference in alfa angle measured by EX-test and EXTEM |
| maximum clot firmness (MCF) in EX-test and EXTEM | through study completion, an average of 3 months | difference in maximum clot firmness measured by EX-test and EXTEM |
| maximum lysis (ML) in EX-test and EXTEM | through study completion, an average of 3 months | maximum lysis difference in MCF measured by EX-test and EXTEM |
| clotting time (CT) FIB-test and FIBTEM | through study completion, an average of 3 months | difference in clotting time measured by FIB-test and FIBTEM |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| maximum clot firmness (MCF) FIB-test and Clauss method | through study completion, an average of 3 months | correlation of maximum clot firmness with blod fibrinogen level |
| maximum clot firmness (MCF) FIBTEM and Clauss method | through study completion, an average of 3 months | correlation of maximum clot firmness with blod fibrinogen level |
| patient temperature | through study completion, an average of 3 months | effect of patients´ temperature on results of measurements |
Countries
Czechia
Outcome results
None listed