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

Not Applicable

Withdrawn

• Conditions: Trauma, Multiple; Massive Hemorrhage; Coagulopathy
• Interventions: Procedure: Trauma-induced coagulopathy treatment

• Registration Number: NCT03380767
• Lead Sponsor: A.O. Ospedale Papa Giovanni XXIII

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-12-17
• Study First Submitted QC: 2017-12-20
• Study First Posted: 2017-12-21
• Study Start: 2019-12
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-01
• Last Update Posted: 2021-03-03
• Primary Completion: 2021-06
• Study Completion: 2021-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional group	Trauma-induced coagulopathy treatment	In this group, patients will be treated according to the information gathered by conventional laboratory assays (platelet count, fibrinogen level, PT or INR and d dimer for fibrinolysis)
POC group	Trauma-induced coagulopathy treatment	In this group, patients will be treated according to the information gathered by TEG or ROTEM assays.

Primary Outcome Measures

Name	Time	Method
Fresh frozen plasma consumption	3 years	In the POC group plasma consumption is estimated 20% less than in conventional assays group

Secondary Outcome Measures

Name	Time	Method
Mortality	28 days	28 days mortality

Trial Locations

Locations (1)

Ospedale Papa Giovanni XXIII; 🇮🇹 Bergamo, BG, Italy