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
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 1,604
- Locations
- 25
- Primary Endpoint
- Number of Participants With Mortality From Any Cause
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 16 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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
Arms & Interventions
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).
Intervention: Cryoprecipitate (Biological)
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).
Intervention: Red Blood Cells (Biological)
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).
Intervention: Plasma (Biological)
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).
Intervention: Platelets (Biological)
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).
Intervention: Whole Blood (Biological)
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.
Intervention: Red Blood Cells (Biological)
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.
Intervention: Plasma (Biological)
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.
Intervention: Platelets (Biological)
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.
Intervention: Whole Blood (Biological)
Outcomes
Primary Outcomes
Number of Participants With Mortality From Any Cause
Time Frame: 28 days after emergency department (ED) admission
Mortality from any cause
Secondary Outcomes
- All Cause Mortality at 6 Hours(6 hours after ED admission)
- Death From Bleeding at 6 Hours(6 hours after ED admission)
- Death From Bleeding at 24 Hours(24 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)
- Quality of Life as Assessed by the Glasgow Outcome Score(6 months after ED admission)
- Hospital Resource Use as Assessed by Number of Ventilator Days(Day of hospital discharge or 28 days after ED admission (whichever comes first))
- Hospital Resource Use as Assessed by Number of Intensive Care Unit (ICU) Days(Day of hospital discharge or 28 days after ED admission (whichever comes first))
- All Cause Mortality at 12 Months(12 months after ED admission)
- Transfusion Requirements (Number of Units of Red Blood Cells (RBCs))(from time of pre-hospital care to 24 hours after ED admission, an average of 30 hours)
- Transfusion Requirements (Number of Units of Platelets)(from time of pre-hospital care to 24 hours after ED admission, an average of 30 hours)
- Transfusion Requirements (Number of Units of Cryoprecipitate)(from time of pre-hospital care to 24 hours after ED admission, an average of 30 hours)
- Hospital Resource Use as Assessed by Number of Hospital Days(Day of hospital discharge or 28 days after ED admission (whichever comes first))
- Transfusion Requirements (Number of Units of Plasma)(from time of pre-hospital care to 24 hours after ED admission, an average of 30 hours)
- Destination of Participant at Time of Discharge From Hospital(at the time of discharge from hospital, about 11-27 days after admission)
- Quality of Life as Assessed by EuroQol-5 Dimension-5 Level (EQ5D-5L)(6 months after ED admission)
Investigators
Bryan Cotton
Professor of Surgery
The University of Texas Health Science Center, Houston