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Use of Viscoelastic Tests in the Treatment of Traumatic Induced Coagulopathy: a Pragmatic Randomized Clinical Trial.

NCT03380767 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2021-03-03

No results posted yet for this study

Summary

Trauma is the leading cause of death in young people. Trauma-induced coagulopathy (TIC) encompasses several aspects of traumatic bleeding. Monitoring of coagulopathy comprises use of Point-of-Care (POC) methods, such as thromboelastography (TEG) or Thromboelastometry (ROTEM) and conventional laboratory assays (platelet count, fibrinogen level, and PT or INR).

POC tests are thought to have a better performance on mortality and bleeding control than conventional tests. The aim of this study is to compare POC and conventional assays with plasma consumption as a primary outcome and 28 days mortality as a secondary one.

Conditions

  • Trauma, Multiple
  • Coagulopathy
  • Massive Hemorrhage

Interventions

PROCEDURE

Trauma-induced coagulopathy treatment

Transfusion as needed according to the assay methodology

Sponsors & Collaborators

  • A.O. Ospedale Papa Giovanni XXIII

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-31
Primary Completion
2021-06-30
Completion
2021-09-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03380767 on ClinicalTrials.gov