An observational study in Polytrauma and Coagulation Disorder, sponsored by Masaryk University. Completed at 1 site in Czechia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by Masaryk University · Observational
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 approval by the Research Ethics Committee. All patients admitted to the emergency department for trauma from October 1, 2019, to January 31, 2020, will be enrolled after fulfilling the inclusion criteria and in the absence of any exclusion criteria. Informed consent will be requested.
Viscoelastic coagulation tests will be performed simultaneously using ROTEM® Delta and ClotPro®. The investigators will compare the values of clotting time (CT), clot formation time (CFT), alpha angle, maximum clot firmness (MCF), and maximum lysis (ML) obtained from the extrinsic pathway test (EX-test) on ClotPro® with those obtained from the extrinsic pathway test (EXTEM) on ROTEM® Delta.
Furthermore, the investigators will compare the values of clotting time (CT), clot formation time (CFT), alpha angle, maximum clot firmness (MCF), and maximum lysis (ML) obtained from the fibrinogen test (FIB-test) on ClotPro® with those obtained from fibrinogen thromboelastometry (FIBTEM) on ROTEM® Delta.
The secondary outcome will be to assess the relationship between measurement results and patient temperature.
Study data will be entered into a study form. Measurements may be repeated over time. The indication for subsequent measurements will be determined solely by the treating physician.
Differences in estimated viscoelastic coagulation parameters and the interchangeability of the two devices will be analysed.
139 studies on the registry are indexed under Multiple Trauma; 32 are open to participants now.
This study's enrollment of 108 is below the median of 200 across 84 observational studies indexed under Multiple Trauma.
Browse Multiple Trauma studies →Masaryk University is the lead sponsor of 47 studies on the registry; 20 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult patients admitted to emnergency department for severe trauma.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Clotting time (CT) in EX-test and EXTEM
difference in clotting time measured by EX-test and EXTEM
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: through study completion, an average of 3 months
alfa angle FIB-test and FIBTEM
difference in alfa angle measured by FIB-test and FIBTEM
Time frame: 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
Time frame: through study completion, an average of 3 months
patient temperature
effect of patients´ temperature on results of measurements
Time frame: 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
Time frame: 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
Time frame: through study completion, an average of 3 months
Plan to share: No
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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Masaryk University