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

Coagulopathy Clinical Trial

— 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.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03380767
• Other study ID #: Trauma Study
• Status: Withdrawn
• Phase: N/A
• Start date: December 2019
• Est. completion date: September 2021

Study information

• Verified date: March 2021
• Source: A.O. Ospedale Papa Giovanni XXIII
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Coagulopathy
• Hemorrhage
• Hemostatic Disorders
• Massive Hemorrhage
• Multiple Trauma
• Trauma, Multiple
• Wounds and Injuries

Intervention

Procedure:
• Trauma-induced coagulopathy treatment
Transfusion as needed according to the assay methodology

Locations

Country	Name	City	State
Italy	Ospedale Papa Giovanni XXIII	Bergamo	BG

Sponsors (1)

Lead Sponsor	Collaborator
A.O. Ospedale Papa Giovanni XXIII

Country where clinical trial is conducted

Italy, 

References & Publications (3)

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. — View 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. Review. — View 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;(2):CD010438. doi: 10.1002/14651858.CD010438.pub2. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fresh frozen plasma consumption	In the POC group plasma consumption is estimated 20% less than in conventional assays group	3 years
Secondary	Mortality	28 days mortality	28 days