Clinical trial NCT04107818: Comparison of Viscoelastic Measurement by ROTEM® Delta and ClotPro® in Trauma Patients.
Official title: Comparison of Viscoelastic Measurement by ROTEM® Delta and ClotPro® in Trauma Patients. Prospective Observational Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Polytrauma
Coagulation Disorder
Keywords: polytrauma
coagulopathy
viscoelastic tests
Lead sponsor: Masaryk University
Sponsor class: OTHER
Collaborators: name: Brno University Hospital
First posted: 2019-09-27
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients admitted to emnergency department for severe trauma.

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.

Eligibility criteria: Inclusion Criteria:

* age ≥18 years
* polytrauma with Injury severity score ≥ 16

Exclusion Criteria:

* pregnancy
* anticoagulant therapy
* antiplatelet therapy
* coagulation disorders

Primary outcomes:
measure: Clotting time (CT) in EX-test and EXTEM
timeFrame: through study completion, an average of 3 months
measure: Clot formation time (CFT) in EX-test and EXTEM
timeFrame: through study completion, an average of 3 months
measure: alfa angle in EX-test and EXTEM
timeFrame: through study completion, an average of 3 months
measure: maximum clot firmness (MCF) in EX-test and EXTEM
timeFrame: through study completion, an average of 3 months
measure: maximum lysis (ML) in EX-test and EXTEM
timeFrame: through study completion, an average of 3 months
measure: clotting time (CT) FIB-test and FIBTEM
timeFrame: through study completion, an average of 3 months
measure: clot formation time (CFT) FIB-test and FIBTEM
timeFrame: through study completion, an average of 3 months
measure: maximum clot firmness (MCF) FIB-test and FIBTEM
timeFrame: through study completion, an average of 3 months
measure: alfa angle FIB-test and FIBTEM
timeFrame: through study completion, an average of 3 months
measure: maximum lysis (ML) FIB-test and FIBTEM
timeFrame: through study completion, an average of 3 months
Secondary outcomes:
measure: patient temperature
timeFrame: through study completion, an average of 3 months
measure: maximum clot firmness (MCF) FIB-test and Clauss method
timeFrame: through study completion, an average of 3 months
measure: maximum clot firmness (MCF) FIBTEM and Clauss method
timeFrame: through study completion, an average of 3 months
Other outcomes:
Locations:
city: Brno
country: Czechia
facility: University Hospital Brno and Masaryk University Brno
Study officials:
affiliation: University Hospital Brno and Masaryk University Brno
name: Roman Gal, MD., PhD.
role: STUDY_CHAIR
References: