Status:
COMPLETED
Early Use of Cryoprecipitate With Major Hemorrhage Protocol (MHP) Activation
Lead Sponsor:
Bryan Cotton
Collaborating Sponsors:
Queen Mary University of London
NHS Blood and Transplant
Conditions:
Trauma Injury
Eligibility:
All Genders
16+ years
Phase:
PHASE3
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 depart...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2022
Estimated Enrollment :
1604 Patients enrolled
Trial Details
Trial ID
NCT04704869
Start Date
January 1 2017
End Date
November 1 2022
Last Update
January 14 2025
Active Locations (25)
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1
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
2
Queen Elizabeth Hospital
Birmingham, United Kingdom, B15 2TH
3
Royal Sussex County Hospital
Brighton, United Kingdom, BN2N 5BE
4
Southmead Hospital
Bristol, United Kingdom, BS10 5NB