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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 and interchangeability in measurements of viscoelastic tests of coagulation by two different devices in adult trauma patients.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
University Hospital Brno and Masaryk University Brno
Brno, Czechia
Start Date
November 21, 2019
Primary Completion Date
October 13, 2021
Completion Date
October 13, 2021
Last Updated
May 22, 2024
108
ACTUAL participants
Lead Sponsor
Masaryk University
Collaborators
NCT07480655
NCT05156983
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06403163