Trauma, MultipleVISCOTRAUMANCT03380767
Use of Viscoelastic Tests in the Treatment of Traumatic Induced Coagulopathy: a Pragmatic Randomized Clinical Trial.
A study testing Trauma-induced coagulopathy treatment in people with Trauma, Multiple and Coagulopathy, run by A.O. Ospedale Papa Giovanni XXIII at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Trauma, Multiple, Coagulopathy, Massive Hemorrhage
- What is being tested?
- Trauma-induced coagulopathy treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteItaly
- Study dates
- Dec 2019to Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- dead on arrival
- no blood product administered after randomization
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Viscoelastic Tests in the Treatment of Trauma-induced Coagulopathy: a Pragmatic Randomized Clinical Trial Comparing Viscoelastic Tests With Conventional Assays.
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.
- Conditions
- Trauma, Multiple, Coagulopathy, Massive Hemorrhage
- Being tested
- Trauma-induced coagulopathy treatment
- Keywords
- trauma-induced coagulopathy
- Medical subject headings
- Multiple Trauma, Hemostatic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trauma-induced coagulopathy treatmentProcedure or surgery
Transfusion as needed according to the assay methodology
| Study group | Role | What they receive |
|---|---|---|
| POC group | Experimental | In this group, patients will be treated according to the information gathered by TEG or ROTEM assays. Receives: 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) Receives: Procedure: Trauma-induced coagulopathy treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fresh frozen plasma consumption
In the POC group plasma consumption is estimated 20% less than in conventional assays group
Measured: 3 years
Secondary outcomes (1)
Mortality
28 days mortality
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2017
- Study startDec 2019 (estimated)
- Primary completionJun 2021 (estimated)
- Study completionSep 2021 (estimated)
Why it stopped: Lack of financial support
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Trauma, MultipleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pragmatic randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- A.O. Ospedale Papa Giovanni XXIII
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefano Magnone, A.O. Ospedale Papa Giovanni XXIII
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03380767
- Sponsor's protocol ID
- Trauma Study
- Acronym
- VISCOTRAUMA
- Status last verified
- Mar 2021
- First submitted
- 17 Dec 2017
- Last updated
- 3 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 27894492Gonzalez 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 26720428Hunt 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
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Viscoelastic Tests in the Treatment of Trauma-induced Coagulopathy: a Pragmatic Randomized Clinical Trial Comparing Viscoelastic Tests With Conventional Assays.
- ClinicalTrials.gov ID
- NCT03380767
- Acronym / sponsor ID
- VISCOTRAUMA / Trauma Study
- Conditions
- Trauma, Multiple, Coagulopathy, Massive Hemorrhage
- Keywords
- trauma-induced coagulopathy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of financial support
- Enrolment
- 0 participants (actual)
- Lead sponsor
- A.O. Ospedale Papa Giovanni XXIIIUniversity, hospital or other
- Study start
- Dec 2019 (estimated)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 21 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pragmatic randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| POC group | Experimental | Procedure: Trauma-induced coagulopathy treatmentIn this group, patients will be treated according to the information gathered by TEG or ROTEM assays. |
| Conventional group | Experimental | Procedure: Trauma-induced coagulopathy treatmentIn 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) |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- dead on arrival
- no blood product administered after randomization
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trauma-induced coagulopathy treatmentTransfusion as needed according to the assay methodology | Procedure or surgery | Conventional group, POC group |
Primary outcome
Fresh frozen plasma consumption
Time frame: 3 years
In the POC group plasma consumption is estimated 20% less than in conventional assays group
1 secondary outcome
Mortality
Time frame: 28 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2021.
- Background: PubMed 27894492Gonzalez 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.
- Background: PubMed 26720428Gonzalez 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.
- Background: PubMed 25686465Hunt 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trauma-induced coagulopathy treatment in people with Trauma, Multiple and Coagulopathy, run by A.O. Ospedale Papa Giovanni XXIII at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fresh frozen plasma consumption (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03380767, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2021.