NCT03380767

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2019

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 17, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 21, 2017

Completed
1.9 years until next milestone

Study Start

First participant enrolled

December 1, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

March 3, 2021

Status Verified

March 1, 2021

Enrollment Period

1.5 years

First QC Date

December 17, 2017

Last Update Submit

March 1, 2021

Conditions

Trauma, MultipleCoagulopathyMassive Hemorrhage

Keywords

trauma-induced coagulopathy

Outcome Measures

Primary Outcomes (1)

  • Fresh frozen plasma consumption

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

    3 years

Secondary Outcomes (1)

  • Mortality

    28 days

Study Arms (2)

POC group

EXPERIMENTAL

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

Procedure: Trauma-induced coagulopathy treatment

Conventional group

EXPERIMENTAL

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

Interventions

Trauma-induced coagulopathy treatmentPROCEDURE

Transfusion as needed according to the assay methodology

Conventional groupPOC group

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • dead on arrival
  • no blood product administered after randomization

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ospedale Papa Giovanni XXIII

Bergamo, BG, 24127, Italy

Location

Related Publications (3)

  • 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.

    PMID: 27894492BACKGROUND

  • 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.

    PMID: 26720428BACKGROUND

  • 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.

    PMID: 25686465BACKGROUND

MeSH Terms

Conditions

Multiple TraumaHemostatic Disorders

Condition Hierarchy (Ancestors)

Wounds and InjuriesVascular DiseasesCardiovascular DiseasesHemorrhagic DisordersHematologic DiseasesHemic and Lymphatic Diseases
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Pragmatic randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending General Surgeon

Study Record Dates

First Submitted

December 17, 2017

First Posted

December 21, 2017

Study Start

December 1, 2019

Primary Completion

June 1, 2021

Study Completion

September 1, 2021

Last Updated

March 3, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)