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

Study Overview
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Brief Summary
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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.

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

Conditions
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Trauma, Multiple, Coagulopathy, Massive Hemorrhage

Intervention / Treatment
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* Procedure: Trauma-induced coagulopathy treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Pragmatic randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: POC group<br>In this group, patients will be treated according to the information gathered by TEG or ROTEM assays. | Procedure: Trauma-induced coagulopathy treatment<br>* Transfusion as needed according to the assay methodology<br>|
| Experimental: Conventional group<br>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) | Procedure: Trauma-induced coagulopathy treatment<br>* Transfusion as needed according to the assay methodology<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fresh frozen plasma consumption | In the POC group plasma consumption is estimated 20% less than in conventional assays group | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | 28 days mortality | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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trauma-induced coagulopathy