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

Primary Purpose

Trauma, Multiple, Coagulopathy, Massive Hemorrhage

Status

Withdrawn

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

Trauma-induced coagulopathy treatment

About this trial

This is an interventional treatment trial for Trauma, Multiple focused on measuring trauma-induced coagulopathy

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Ospedale Papa Giovanni XXIII

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

POC group

Conventional group

Arm Description

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

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)

Outcomes

Primary Outcome Measures

Fresh frozen plasma consumption

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

Secondary Outcome Measures

Mortality

28 days mortality

Full Information

NCT ID

NCT03380767

First Posted

December 17, 2017

Last Updated

March 1, 2021

Sponsor

A.O. Ospedale Papa Giovanni XXIII

1. Study Identification

Unique Protocol Identification Number

NCT03380767

Brief Title

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

Acronym

VISCOTRAUMA

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Withdrawn

Why Stopped

Lack of financial support

Study Start Date

December 2019 (Anticipated)

Primary Completion Date

June 2021 (Anticipated)

Study Completion Date

September 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

A.O. Ospedale Papa Giovanni XXIII

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Trauma, Multiple, Coagulopathy, Massive Hemorrhage

Keywords

trauma-induced coagulopathy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Pragmatic randomized controlled trial

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

POC group

Arm Type

Experimental

Arm Description

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

Arm Title

Conventional group

Arm Type

Experimental

Arm 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)

Intervention Type

Procedure

Intervention Name(s)

Trauma-induced coagulopathy treatment

Intervention Description

Transfusion as needed according to the assay methodology

Primary Outcome Measure Information:

Title

Fresh frozen plasma consumption

Description

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

Time Frame

3 years

Secondary Outcome Measure Information:

Title

Mortality

Description

28 days mortality

Time Frame

28 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

Ospedale Papa Giovanni XXIII

City

Bergamo

State/Province

ZIP/Postal Code

24127

Country

Italy

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

27894492

Citation

Gonzalez E, Moore EE, Moore HB. Management of Trauma-Induced Coagulopathy with Thrombelastography. Crit Care Clin. 2017 Jan;33(1):119-134. doi: 10.1016/j.ccc.2016.09.002.

Results Reference

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PubMed Identifier

26720428

Citation

Gonzalez E, Moore EE, Moore HB, Chapman MP, Chin TL, Ghasabyan A, Wohlauer MV, Barnett CC, Bensard DD, Biffl WL, Burlew CC, Johnson JL, Pieracci FM, Jurkovich GJ, Banerjee A, Silliman CC, Sauaia A. Goal-directed Hemostatic Resuscitation of Trauma-induced Coagulopathy: A Pragmatic Randomized Clinical Trial Comparing a Viscoelastic Assay to Conventional Coagulation Assays. Ann Surg. 2016 Jun;263(6):1051-9. doi: 10.1097/SLA.0000000000001608.

Results Reference

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PubMed Identifier

25686465

Citation

Hunt H, Stanworth S, Curry N, Woolley T, Cooper C, Ukoumunne O, Zhelev Z, Hyde C. Thromboelastography (TEG) and rotational thromboelastometry (ROTEM) for trauma induced coagulopathy in adult trauma patients with bleeding. Cochrane Database Syst Rev. 2015 Feb 16;2015(2):CD010438. doi: 10.1002/14651858.CD010438.pub2.

Results Reference

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Learn more about this trial

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

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