Early Use of Cryoprecipitate With Major Hemorrhage Protocol (MHP) Activation
A Multi-center, Randomized, Controlled Trial Evaluating the Effects of Early High-Dose Cryoprecipitate in Adult Patients With Major Trauma Hemorrhage Requiring Major Hemorrhage Protocol (MHP) Activation
2 other identifiers
interventional
1,604
2 countries
25
Brief Summary
The purpose of this trial is to compare standard of care (SOC) massive transfusion protocol to SOC massive transfusion protocol plus early use of cryoprecipitate (within 90 minutes of emergency department arrival).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 2017
Longer than P75 for phase_3
25 active sites
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
Study Start
First participant enrolled
January 1, 2017
CompletedFirst Submitted
Initial submission to the registry
January 6, 2021
CompletedFirst Posted
Study publicly available on registry
January 12, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2022
CompletedResults Posted
Study results publicly available
February 21, 2023
CompletedJanuary 14, 2025
December 1, 2024
4.9 years
January 6, 2021
December 1, 2022
December 20, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants With Mortality From Any Cause
Mortality from any cause
28 days after emergency department (ED) admission
Secondary Outcomes (18)
All Cause Mortality at 6 Hours
6 hours after ED admission
All Cause Mortality at 24 Hours
24 hours after ED admission
All Cause Mortality at 6 Months
6 months after ED admission
All Cause Mortality at 12 Months
12 months after ED admission
Death From Bleeding at 6 Hours
6 hours after ED admission
- +13 more secondary outcomes
Study Arms (2)
Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood)
EXPERIMENTALCryoprecipitate 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).
Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood)
ACTIVE COMPARATOROnly standard of care massive transfusion protocol products will be given, including red blood cells, plasma, platelets, and whole blood.
Interventions
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).
RBCs are utilized as part of the Massive Transfusion protocol for hemorrhage control.
Plasma is utilized as part of the Massive Transfusion protocol for hemorrhage control.
Platelets are utilized as part of the Massive Transfusion protocol for hemorrhage control.
Whole Blood is utilized as part of the Massive Transfusion protocol for hemorrhage control.
Eligibility Criteria
You may qualify if:
- The patient is judged to be an adult (according to local practice, e.g. 16 years or older in UK) and has sustained severe traumatic injury. In the event the age is unknown, estimated body weight ≥50 kg.
- 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
You may not qualify if:
- The patient has been transferred from another hospital
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bryan Cottonlead
- Queen Mary University of Londoncollaborator
- NHS Blood and Transplantcollaborator
Study Sites (25)
The University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
Queen Elizabeth Hospital
Birmingham, B15 2TH, United Kingdom
Royal Sussex County Hospital
Brighton, BN2N 5BE, United Kingdom
Southmead Hospital
Bristol, BS10 5NB, United Kingdom
Addenbrooke's Hospital
Cambridge, CB2 0QQ, United Kingdom
University Hospital of Wales
Cardiff, CF14 4XW, United Kingdom
University Hospital of Coventry and Warwickshire
Coventry, CV2 2DX, United Kingdom
Hull Royal Infirmary
Hull, HU3 2JZ, United Kingdom
Leeds General Infirmary
Leeds, LS1 3EX, United Kingdom
University Hospital Aintree
Liverpool, L9 7AL, United Kingdom
Royal London Hospital
London, E1 1BB, United Kingdom
King's College Hospital
London, SE5 9RS, United Kingdom
St. George's Hospital
London, SW17 0QT, United Kingdom
St. Mary's Hospital
London, W2 1NY, United Kingdom
Manchester Royal Infirmary
Manchester, M13 9WL, United Kingdom
Salford Royal Hospital
Manchester, M6 8HD, United Kingdom
James Cook University Hospital
Middlesbrough, TS4 3BW, United Kingdom
Royal Victoria Infirmary
Newcastle upon Tyne, NE1 4LP, United Kingdom
Queens Medical Centre
Nottingham, NG7 2UH, United Kingdom
John Radcliffe Hospital
Oxford, OX3 9UD, United Kingdom
Derriford Hospital
Plymouth, PL6 8DH, United Kingdom
Royal Preston Hospital
Preston, PR2 9HT, United Kingdom
Northern General Hospital
Sheffield, S5 7AU, United Kingdom
University Hospital Southampton
Southampton, SO16 6YD, United Kingdom
University Hospital of North Staffordshire
Stoke-on-Trent, ST4 6QG, United Kingdom
Related Publications (1)
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.
PMID: 37824155RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Bryan A Cotton, MD
- Organization
- The University of Texas Health Science Center at Houston
Study Officials
- PRINCIPAL INVESTIGATOR
Bryan A Cotton, MD
The University of Texas Health Science Center, Houston
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor of Surgery
Study Record Dates
First Submitted
January 6, 2021
First Posted
January 12, 2021
Study Start
January 1, 2017
Primary Completion
December 1, 2021
Study Completion
November 1, 2022
Last Updated
January 14, 2025
Results First Posted
February 21, 2023
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will not share