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Completed

NCT Number: NCT04107818

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Brno and Masaryk University Brno

Brno, 62500, Czechia

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • pregnancy
  • anticoagulant therapy
  • antiplatelet therapy
  • coagulation disorders

Treatment and study plan

Primary outcomes

  1. Clotting time (CT) in EX-test and EXTEM

    Time frame: through study completion, an average of 3 months

    difference in clotting time measured by EX-test and EXTEM

  2. Clot formation time (CFT) in EX-test and EXTEM

    Time frame: through study completion, an average of 3 months

    difference in clot formation time measured by EX-test and EXTEM

  3. alfa angle in EX-test and EXTEM

    Time frame: through study completion, an average of 3 months

    difference in alfa angle measured by EX-test and EXTEM

  4. maximum clot firmness (MCF) in EX-test and EXTEM

    Time frame: through study completion, an average of 3 months

    difference in maximum clot firmness measured by EX-test and EXTEM

  5. maximum lysis (ML) in EX-test and EXTEM

    Time frame: through study completion, an average of 3 months

    maximum lysis difference in MCF measured by EX-test and EXTEM

  6. clotting time (CT) FIB-test and FIBTEM

    Time frame: through study completion, an average of 3 months

    difference in clotting time measured by FIB-test and FIBTEM

  7. clot formation time (CFT) FIB-test and FIBTEM

    Time frame: through study completion, an average of 3 months

    difference in clot formation time measured by FIB-test and FIBTEM

  8. maximum clot firmness (MCF) FIB-test and FIBTEM

    Time frame: through study completion, an average of 3 months

    difference in maximum clot firmness measured by FIB-test and FIBTEM

  9. alfa angle FIB-test and FIBTEM

    Time frame: through study completion, an average of 3 months

    difference in alfa angle measured by FIB-test and FIBTEM

  10. maximum lysis (ML) FIB-test and FIBTEM

    Time frame: through study completion, an average of 3 months

    difference in maximum lysis measured by FIB-test and FIBTEM

Secondary outcomes

  1. patient temperature

    Time frame: through study completion, an average of 3 months

    effect of patients´ temperature on results of measurements

  2. maximum clot firmness (MCF) FIB-test and Clauss method

    Time frame: through study completion, an average of 3 months

    correlation of maximum clot firmness with blod fibrinogen level

  3. maximum clot firmness (MCF) FIBTEM and Clauss method

    Time frame: through study completion, an average of 3 months

    correlation of maximum clot firmness with blod fibrinogen level

Sponsors and collaborators

Lead sponsor

Masaryk University

Other

Collaborators

  • Brno University Hospital

Registry information

Official study title

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

Acronym: ROTCLOT

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Sep 27, 2019
Registry last updated
May 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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