Use of Viscoelastic Tests in the Treatment of Traumatic Induced Coagulopathy: a Pragmatic Randomized Clinical Trial.
NCT ID: NCT03380767
Last Updated: 2021-03-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2019-12-31
2021-09-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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POC group
In this group, patients will be treated according to the information gathered by TEG or ROTEM assays.
Trauma-induced coagulopathy treatment
Transfusion as needed according to the assay methodology
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)
Trauma-induced coagulopathy treatment
Transfusion as needed according to the assay methodology
Interventions
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Trauma-induced coagulopathy treatment
Transfusion as needed according to the assay methodology
Eligibility Criteria
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Exclusion Criteria
* no blood product administered after randomization
18 Years
90 Years
ALL
No
Sponsors
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A.O. Ospedale Papa Giovanni XXIII
OTHER
Responsible Party
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Stefano Magnone
Attending General Surgeon
Locations
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Ospedale Papa Giovanni XXIII
Bergamo, BG, Italy
Countries
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References
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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.
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.
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.
Other Identifiers
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Trauma Study
Identifier Type: -
Identifier Source: org_study_id
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