Early Use of Cryoprecipitate With Major Hemorrhage Protocol (MHP) Activation
NCT ID: NCT04704869
Last Updated: 2025-01-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1604 participants
INTERVENTIONAL
2017-01-31
2022-11-01
Brief Summary
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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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Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood)
Cryoprecipitate will be given in addition to the standard of care massive transfusion protocol products, which include red blood cells, plasma, platelets and whole blood. The Cryoprecipitate will be given with 90 minutes of emergency department arrival. Cryoprecipitate dose will be 3 pools (equivalent to 15 single units).
Cryoprecipitate
Cryoprecipitate is a blood product high in fibrinogen. The Cryoprecipitate will be given with 90 minutes of emergency department arrival. Cryoprecipitate dose will be 3 pools (equivalent to 15 single units).
Red Blood Cells
RBCs are utilized as part of the Massive Transfusion protocol for hemorrhage control.
Plasma
Plasma is utilized as part of the Massive Transfusion protocol for hemorrhage control.
Platelets
Platelets are utilized as part of the Massive Transfusion protocol for hemorrhage control.
Whole Blood
Whole Blood is utilized as part of the Massive Transfusion protocol for hemorrhage control.
Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood)
Only standard of care massive transfusion protocol products will be given, including red blood cells, plasma, platelets, and whole blood.
Red Blood Cells
RBCs are utilized as part of the Massive Transfusion protocol for hemorrhage control.
Plasma
Plasma is utilized as part of the Massive Transfusion protocol for hemorrhage control.
Platelets
Platelets are utilized as part of the Massive Transfusion protocol for hemorrhage control.
Whole Blood
Whole Blood is utilized as part of the Massive Transfusion protocol for hemorrhage control.
Interventions
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Cryoprecipitate
Cryoprecipitate is a blood product high in fibrinogen. The Cryoprecipitate will be given with 90 minutes of emergency department arrival. Cryoprecipitate dose will be 3 pools (equivalent to 15 single units).
Red Blood Cells
RBCs are utilized as part of the Massive Transfusion protocol for hemorrhage control.
Plasma
Plasma is utilized as part of the Massive Transfusion protocol for hemorrhage control.
Platelets
Platelets are utilized as part of the Massive Transfusion protocol for hemorrhage control.
Whole Blood
Whole Blood is utilized as part of the Massive Transfusion protocol for hemorrhage control.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* The patient is deemed by the attending clinician to have on-going active hemorrhage AND REQUIRES Activation of the local major hemorrhage protocol for management of severe blood loss AND HAS STARTED or HAS RECEIVED at least one unit of any blood component
Exclusion Criteria
* The trauma team leader deems the injuries incompatible with life
* More than 3 hours have elapsed from the time of injury
* Prisoner (as defined as someone admitted from a correctional facility)
* Known "Do Not Resuscitate" orders
* Enrolled in a concurrent ongoing interventional, randomized clinical trial
* Patients who wear "opt out" bracelet for study
* Obvious pregnancy
* Severely burned
16 Years
ALL
No
Sponsors
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Queen Mary University of London
OTHER
NHS Blood and Transplant
OTHER_GOV
Bryan Cotton
OTHER
Responsible Party
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Bryan Cotton
Professor of Surgery
Principal Investigators
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Bryan A Cotton, MD
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston
Locations
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The University of Texas Health Science Center at Houston
Houston, Texas, United States
Queen Elizabeth Hospital
Birmingham, , United Kingdom
Royal Sussex County Hospital
Brighton, , United Kingdom
Southmead Hospital
Bristol, , United Kingdom
Addenbrooke's Hospital
Cambridge, , United Kingdom
University Hospital of Wales
Cardiff, , United Kingdom
University Hospital of Coventry and Warwickshire
Coventry, , United Kingdom
Hull Royal Infirmary
Hull, , United Kingdom
Leeds General Infirmary
Leeds, , United Kingdom
University Hospital Aintree
Liverpool, , United Kingdom
Royal London Hospital
London, , United Kingdom
King's College Hospital
London, , United Kingdom
St. George's Hospital
London, , United Kingdom
St. Mary's Hospital
London, , United Kingdom
Manchester Royal Infirmary
Manchester, , United Kingdom
Salford Royal Hospital
Manchester, , United Kingdom
James Cook University Hospital
Middlesbrough, , United Kingdom
Royal Victoria Infirmary
Newcastle upon Tyne, , United Kingdom
Queens Medical Centre
Nottingham, , United Kingdom
John Radcliffe Hospital
Oxford, , United Kingdom
Derriford Hospital
Plymouth, , United Kingdom
Royal Preston Hospital
Preston, , United Kingdom
Northern General Hospital
Sheffield, , United Kingdom
University Hospital Southampton
Southampton, , United Kingdom
University Hospital of North Staffordshire
Stoke-on-Trent, , United Kingdom
Countries
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References
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Davenport R, Curry N, Fox EE, Thomas H, Lucas J, Evans A, Shanmugaranjan S, Sharma R, Deary A, Edwards A, Green L, Wade CE, Benger JR, Cotton BA, Stanworth SJ, Brohi K; CRYOSTAT-2 Principal Investigators. Early and Empirical High-Dose Cryoprecipitate for Hemorrhage After Traumatic Injury: The CRYOSTAT-2 Randomized Clinical Trial. JAMA. 2023 Nov 21;330(19):1882-1891. doi: 10.1001/jama.2023.21019.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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ISRCTN14998314
Identifier Type: REGISTRY
Identifier Source: secondary_id
HSC-MS-19-0272
Identifier Type: -
Identifier Source: org_study_id
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