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

A.O. Ospedale Papa Giovanni XXIII

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Trauma, Multiple Coagulopathy Massive Hemorrhage

Interventions

Trauma-induced coagulopathy treatmentPROCEDURE

Transfusion as needed according to the assay methodology

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (1)

Ospedale Papa Giovanni XXIII

Bergamo, BG, Italy

Outcomes

Primary Outcomes

Fresh frozen plasma consumption

In the POC group plasma consumption is estimated 20% less than in conventional assays group

Time frame: 3 years

Secondary Outcomes

Mortality

28 days mortality

Time frame: 28 days

Data from ClinicalTrials.gov

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