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

NCT ID: NCT04107818

Last Updated: 2024-05-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 108 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-11-21
• Study Completion Date: 2021-10-13

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.

Conditions

Polytrauma; Coagulation Disorder

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• pregnancy
• anticoagulant therapy
• antiplatelet therapy
• coagulation disorders

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brno University Hospital

OTHER

Sponsor Role: collaborator

Masaryk University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Roman Gal, MD., PhD.

Role: STUDY_CHAIR

University Hospital Brno and Masaryk University Brno

Locations

University Hospital Brno and Masaryk University Brno

Brno, , Czechia

Countries

Czechia

Other Identifiers

CT0022019

Identifier Type: -

Identifier Source: org_study_id