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WithdrawnNCT03380767VISCOTRAUMAUpdated Mar 3, 2021

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

An interventional study of Trauma-induced coagulopathy treatment in Trauma, Multiple, Coagulopathy and Massive Hemorrhage, sponsored by A.O. Ospedale Papa Giovanni XXIII. Withdrawn at 1 site in Italy. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2021-03-03.

Sponsored by A.O. Ospedale Papa Giovanni XXIII · Not applicable, Interventional, and Treatment

Why this study was withdrawn
Lack of financial support
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Trauma, Multiple
  • Coagulopathy
  • Massive Hemorrhage

Keywords

  • trauma-induced coagulopathy
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In context

Multiple Trauma

139 studies on the registry are indexed under Multiple Trauma; 32 are open to participants now.

Browse Multiple Trauma studies →

Lead sponsor

A.O. Ospedale Papa Giovanni XXIII is the lead sponsor of 32 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • ProcedureTrauma-induced coagulopathy treatment

    Transfusion as needed according to the assay methodology

06

What researchers measure

Primary outcomes

  1. Fresh frozen plasma consumption

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

    Time frame: 3 years

Secondary outcomes

  1. Mortality

    28 days mortality

    Time frame: 28 days

07

Study locations

1 site
  • Ospedale Papa Giovanni XXIII
    Bergamo, BG 24127, Italy
08

References and documents

Publications

  • 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. PubMed 27894492 ↗
  • 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. PubMed 26720428 ↗
  • 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. PubMed 25686465 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Dec 2019; primary completion for Jun 2021, 18 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 17, 2017
First posted
Dec 21, 2017
StartEst.
Dec 2019
Primary completionEst.
Jun 2021
CompletionEst.
Sep 2021
Last update
Mar 3, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 3, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03380767
Lead sponsor
A.O. Ospedale Papa Giovanni XXIII
Responsible party
Stefano Magnone (Attending General Surgeon, A.O. Ospedale Papa Giovanni XXIII) — Principal investigator
First posted
Dec 21, 2017
Start date
Dec 2019 (estimated)
Primary completion
Jun 2021 (estimated)
Completion
Sep 2021 (estimated)
Last update
Mar 3, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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