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

A.O. Ospedale Papa Giovanni XXIII

Status: Withdrawn

Conditions: Coagulopathy; Massive Hemorrhage; Trauma, Multiple

Treatments: Procedure: Trauma-induced coagulopathy treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT03380767

Trauma Study

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

POC group

Experimental group

Description:

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

Treatment:

Procedure: Trauma-induced coagulopathy treatment

Conventional group

Experimental group

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)

Treatment:

Procedure: Trauma-induced coagulopathy treatment