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

• Sponsor: A.O. Ospedale Papa Giovanni XXIII (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT03380767
• Collaborator: (none)
• Enrollment: 0
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 21
• Patients Per Site Per Month: 0

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Trauma, Multiple; Coagulopathy; Massive Hemorrhage	Procedure: Trauma-induced coagulopathy treatment	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Pragmatic randomized controlled trialPragmatic randomized controlled trial
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Use of Viscoelastic Tests in the Treatment of Trauma-induced Coagulopathy: a Pragmatic Randomized Clinical Trial Comparing Viscoelastic Tests With Conventional Assays.
• Anticipated Study Start Date: Dec 1, 2019
• Anticipated Primary Completion Date: Jun 1, 2021
• Anticipated Study Completion Date: Sep 1, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Fresh frozen plasma consumption [3 years]

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

Secondary Outcome Measures

1. Mortality [28 days]

   28 days mortality

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ospedale Papa Giovanni XXIII	Bergamo	BG	Italy	24127

Sponsors and Collaborators

• A.O. Ospedale Papa Giovanni XXIII

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.

• Responsible Party: Stefano Magnone, Attending General Surgeon, A.O. Ospedale Papa Giovanni XXIII
• ClinicalTrials.gov Identifier: NCT03380767
• Other Study ID Numbers: Trauma Study
• First Posted: Dec 21, 2017
• Last Update Posted: Mar 3, 2021
• Last Verified: Mar 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Stefano Magnone, Attending General Surgeon, A.O. Ospedale Papa Giovanni XXIII: trauma-induced coagulopathy
• Additional relevant MeSH terms: Hemostatic Disorders; Blood Coagulation Disorders; Hemorrhage; Wounds and Injuries; Multiple Trauma

Study Results

No Results Posted as of Mar 3, 2021