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.

Sponsors

Lead Sponsor: A.O. Ospedale Papa Giovanni XXIII

Source 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.

Overall Status Withdrawn
Start Date 2019-12-01
Completion Date 2021-09-01
Primary Completion Date 2021-06-01
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Fresh frozen plasma consumption 3 years
Secondary Outcome
Measure Time Frame
Mortality 28 days
Condition
Intervention

Intervention Type: Procedure

Intervention Name: Trauma-induced coagulopathy treatment

Description: Transfusion as needed according to the assay methodology

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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

90 Years

Healthy Volunteers:

No

Location
Facility: Ospedale Papa Giovanni XXIII
Location Countries

Italy

Verification Date

2021-03-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: A.O. Ospedale Papa Giovanni XXIII

Investigator Full Name: Stefano Magnone

Investigator Title: Attending General Surgeon

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: POC group

Type: Experimental

Description: In this group, patients will be treated according to the information gathered by TEG or ROTEM assays.

Label: Conventional group

Type: Experimental

Description: 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)

Acronym VISCOTRAUMA
Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Intervention Model Description: Pragmatic randomized controlled trial

Primary Purpose: Treatment

Masking: None (Open Label)

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