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

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 in measurements of viscoelastic tests of coagulation by two different devices in adult trauma patients.

Study Overview

• Status: Recruiting
• Conditions: Coagulation Disorder; Polytrauma

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 will be analysed.

• Study Type: Observational
• Enrollment (Anticipated): 40

Contacts and Locations

• Study Contact: Name: Kamil Vrbica, MD.; Phone Number: +420 532232825; Email: vrbica.kamil@fnbrno.cz
• Study Contact Backup: Name: Ondrej Hrdy, MD.; Phone Number: +420 532232305; Email: hrdy.ondrej@fnbrno.cz

Study Locations

• Czechia
  • Brno, Czechia, 62500
    • Recruiting
    • University Hospital Brno and Masaryk University Brno
    • Contact: Kamil Vrbica, M.D.; Phone Number: +420 532233850; Email: vrbica.kamil@fnbrno.cz
    • Contact: Ondrej Hrdy, M.D.; Phone Number: +420 532232305; Email: hrdy.ondrej@fnbrno.cz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients admitted to emnergency department for severe trauma.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• pregnancy
• anticoagulant therapy
• antiplatelet therapy
• coagulation disorders

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
alfa angle FIB-test and FIBTEM	difference in alfa angle measured by FIB-test and FIBTEM	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	through study completion, an average of 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
patient temperature	effect of patients´ temperature on results of measurements	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	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	through study completion, an average of 3 months

Collaborators and Investigators

• Sponsor: Masaryk University
• Collaborators: Brno University Hospital
• Investigators: Study Chair: Roman Gal, MD., PhD., University Hospital Brno and Masaryk University Brno

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2019
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: August 9, 2019
• First Submitted That Met QC Criteria: September 26, 2019
• First Posted (Actual): September 27, 2019

Study Record Updates

• Last Update Posted (Actual): March 28, 2023
• Last Update Submitted That Met QC Criteria: March 27, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: coagulopathy; polytrauma; viscoelastic tests
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Wounds and Injuries; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Blood Coagulation Disorders; Multiple Trauma
• Other Study ID Numbers: CT0022019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No