Comparison of Viscoelastic Measurement by ROTEM® Delta and ClotPro® in Trauma Patients.

Study Overview
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Brief Summary
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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.

Detailed Description
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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 will be analysed.

Official Title
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Comparison of Viscoelastic Measurement by ROTEM® Delta and ClotPro® in Trauma Patients. Prospective Observational Study.

Conditions
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Polytrauma, Coagulation Disorder

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age ≥18 years polytrauma with Injury severity score ≥ 16 Exclusion Criteria: pregnancy anticoagulant therapy antiplatelet therapy coagulation disorders

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| alfa angle FIB-test and FIBTEM | difference in alfa angle measured by FIB-test and FIBTEM | through study completion, an average of 3 months | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patient temperature | effect of patients´ temperature on results of measurements | through study completion, an average of 3 months | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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polytrauma, coagulopathy, viscoelastic tests