Use of Viscoelastic Tests in the Treatment of Trauma-induced Coagulopathy: a Pragmatic Randomized Clinical Trial Comparing Viscoelastic Tests With Conventional Assays.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Trauma, Multiple
- Sponsor
- A.O. Ospedale Papa Giovanni XXIII
- Locations
- 1
- Primary Endpoint
- Fresh frozen plasma consumption
- Status
- Withdrawn
- Last Updated
- 5 years ago
Overview
Brief 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.
Investigators
Stefano Magnone
Attending General Surgeon
A.O. Ospedale Papa Giovanni XXIII
Eligibility Criteria
Inclusion Criteria
- •all adult (\> 18 years old) trauma patients treated in our Emergency Department with a TASH score \> 18
Exclusion Criteria
- •dead on arrival
- •no blood product administered after randomization
Outcomes
Primary Outcomes
Fresh frozen plasma consumption
Time Frame: 3 years
In the POC group plasma consumption is estimated 20% less than in conventional assays group
Secondary Outcomes
- Mortality(28 days)