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

M

Masaryk University

Status

Completed

Conditions

Coagulation Disorder
Polytrauma

Study type

Observational

Funder types

Other

Identifiers

NCT04107818
CT0022019

Details and patient eligibility

About

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.

Full 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.

Enrollment

108 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • pregnancy
  • anticoagulant therapy
  • antiplatelet therapy
  • coagulation disorders

Trial contacts and locations

1

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Central trial contact

Kamil Vrbica, MD.; Ondrej Hrdy, MD.

Data sourced from clinicaltrials.gov

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