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

Coagulation Disorder Clinical Trial

— ROTCLOT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04107818
• Other study ID #: CT0022019
• Status: Completed
• Start date: November 21, 2019
• Est. completion date: October 13, 2021

Study information

• Verified date: May 2024
• Source: Masaryk University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: October 13, 2021
• Est. primary completion date: October 13, 2021
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• age =18 years

• polytrauma with Injury severity score = 16

Exclusion Criteria:

• pregnancy

• anticoagulant therapy

• antiplatelet therapy

• coagulation disorders

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Coagulation Disorder
• Hemostatic Disorders
• Multiple Trauma
• Polytrauma

Locations

Country	Name	City	State
Czechia	University Hospital Brno and Masaryk University Brno	Brno

Sponsors (2)

Lead Sponsor	Collaborator
Masaryk University	Brno University Hospital

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clotting time (CT) in EX-test and EXTEM	difference in clotting time measured by EX-test and EXTEM	through study completion, an average of 3 months
Primary	Clot formation time (CFT) in EX-test and EXTEM	difference in clot formation time measured by EX-test and EXTEM	through study completion, an average of 3 months
Primary	alfa angle in EX-test and EXTEM	difference in alfa angle measured by EX-test and EXTEM	through study completion, an average of 3 months
Primary	maximum clot firmness (MCF) in EX-test and EXTEM	difference in maximum clot firmness measured by EX-test and EXTEM	through study completion, an average of 3 months
Primary	maximum lysis (ML) in EX-test and EXTEM	maximum lysis difference in MCF measured by EX-test and EXTEM	through study completion, an average of 3 months
Primary	clotting time (CT) FIB-test and FIBTEM	difference in clotting time measured by FIB-test and FIBTEM	through study completion, an average of 3 months
Primary	clot formation time (CFT) FIB-test and FIBTEM	difference in clot formation time measured by FIB-test and FIBTEM	through study completion, an average of 3 months
Primary	maximum clot firmness (MCF) FIB-test and FIBTEM	difference in maximum clot firmness measured by FIB-test and FIBTEM	through study completion, an average of 3 months
Primary	alfa angle FIB-test and FIBTEM	difference in alfa angle measured by FIB-test and FIBTEM	through study completion, an average of 3 months
Primary	maximum lysis (ML) FIB-test and FIBTEM	difference in maximum lysis measured by FIB-test and FIBTEM	through study completion, an average of 3 months
Secondary	patient temperature	effect of patients´ temperature on results of measurements	through study completion, an average of 3 months
Secondary	maximum clot firmness (MCF) FIB-test and Clauss method	correlation of maximum clot firmness with blod fibrinogen level	through study completion, an average of 3 months
Secondary	maximum clot firmness (MCF) FIBTEM and Clauss method	correlation of maximum clot firmness with blod fibrinogen level	through study completion, an average of 3 months