University Hospital Brno and Masaryk University Brno
Brno, 62500, Czechia
NCT Number: NCT04107818
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.
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Notify Me18 year and older
All sexes
Observational
Brno, 62500, Czechia
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.
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: through study completion, an average of 3 months
difference in clotting time measured by EX-test and EXTEM
Time frame: through study completion, an average of 3 months
difference in clot formation time measured by EX-test and EXTEM
Time frame: through study completion, an average of 3 months
difference in alfa angle measured by EX-test and EXTEM
Time frame: through study completion, an average of 3 months
difference in maximum clot firmness measured by EX-test and EXTEM
Time frame: through study completion, an average of 3 months
maximum lysis difference in MCF measured by EX-test and EXTEM
Time frame: through study completion, an average of 3 months
difference in clotting time measured by FIB-test and FIBTEM
Time frame: through study completion, an average of 3 months
difference in clot formation time measured by FIB-test and FIBTEM
Time frame: through study completion, an average of 3 months
difference in maximum clot firmness measured by FIB-test and FIBTEM
Time frame: through study completion, an average of 3 months
difference in alfa angle measured by FIB-test and FIBTEM
Time frame: through study completion, an average of 3 months
difference in maximum lysis measured by FIB-test and FIBTEM
Time frame: through study completion, an average of 3 months
effect of patients´ temperature on results of measurements
Time frame: through study completion, an average of 3 months
correlation of maximum clot firmness with blod fibrinogen level
Time frame: through study completion, an average of 3 months
correlation of maximum clot firmness with blod fibrinogen level
Masaryk University
Other
Comparison of Viscoelastic Measurement by ROTEM® Delta and ClotPro® in Trauma Patients. Prospective Observational Study.
Acronym: ROTCLOT
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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