NCT03380767

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

Use of Viscoelastic Tests in the Treatment of Trauma-induced Coagulopathy: a Pragmatic Randomized Clinical Trial Comparing Viscoelastic Tests With Conventional Assays.

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: A.O. Ospedale Papa Giovanni XXIII · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
PROCEDURE	Trauma-induced coagulopathy treatment	Transfusion as needed according to the assay methodology

Timeline

• Start date: 2019-12-01
• Primary completion: 2021-06-01
• Completion: 2021-09-01
• First posted: 2017-12-21
• Last updated: 2021-03-03

Locations

1 site across 1 country: Italy