Early Use of Cryoprecipitate With Major Hemorrhage Protocol (MHP) Activation
- Conditions
- Trauma Injury
- Interventions
- Biological: Red Blood CellsBiological: CryoprecipitateBiological: PlasmaBiological: Whole BloodBiological: Platelets
- Registration Number
- NCT04704869
- Lead Sponsor
- Bryan Cotton
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1604
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) Plasma Only standard of care massive transfusion protocol products will be given, including red blood cells, plasma, platelets, and whole blood. Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) Whole Blood Only standard of care massive transfusion protocol products will be given, including red blood cells, plasma, platelets, and whole blood. Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) Red Blood Cells Only standard of care massive transfusion protocol products will be given, including red blood cells, plasma, platelets, and whole blood. Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) Red Blood Cells 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). Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) 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). Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) Plasma 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). Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) Platelets 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). Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) Platelets Only standard of care massive transfusion protocol products will be given, including red blood cells, plasma, platelets, and whole blood. Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) Cryoprecipitate 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).
- Primary Outcome Measures
Name Time Method Number of Participants With Mortality From Any Cause 28 days after emergency department (ED) admission Mortality from any cause
- Secondary Outcome Measures
Name Time Method All Cause Mortality at 6 Hours 6 hours after ED admission Mortality from any cause
Death From Bleeding at 6 Hours 6 hours after ED admission Death related to exsanguination
Death From Bleeding at 24 Hours 24 hours after ED admission Death related to exsanguination
All Cause Mortality at 24 Hours 24 hours after ED admission Mortality from any cause
All Cause Mortality at 6 Months 6 months after ED admission Mortality from any cause. All cause mortality at 6 months is presented as a Kaplan-Meier estimated.
Quality of Life as Assessed by the Glasgow Outcome Score 6 months after ED admission The Glasgow Outcome Score ranges from 1 to 5, with a higher score indicating a better outcome:
1. Death - Severe injury or death without recovery of consciousness
2. Persistent vegetative state - Severe damage with prolonged state of unresponsiveness and a lack of higher mental functions
3. Severe disability - Severe injury with permanent need for help with daily living
4. Moderate disability - No need for assistance in everyday life, employment is possible but may require special equipment
5. Low disability - Light damage with minor neurological and psychological deficitsHospital Resource Use as Assessed by Number of Ventilator Days Day of hospital discharge or 28 days after ED admission (whichever comes first) Number of ventilator days during hospitalization
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) Number of ICU days during hospitalization
All Cause Mortality at 12 Months 12 months after ED admission Mortality from any cause. All cause mortality at 6 months is presented as a Kaplan-Meier estimated.
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 Number of units of RBCs
Transfusion Requirements (Number of Units of Platelets) from time of pre-hospital care to 24 hours after ED admission, an average of 30 hours Number of units of platelets
Transfusion Requirements (Number of Units of Cryoprecipitate) from time of pre-hospital care to 24 hours after ED admission, an average of 30 hours Number of units of cryoprecipitate
Hospital Resource Use as Assessed by Number of Hospital Days Day of hospital discharge or 28 days after ED admission (whichever comes first) Total number of hospital days
Transfusion Requirements (Number of Units of Plasma) from time of pre-hospital care to 24 hours after ED admission, an average of 30 hours Number of units of plasma
Destination of Participant at Time of Discharge From Hospital at the time of discharge from hospital, about 11-27 days after admission Destination of participant at time of discharge from hospital
Quality of Life as Assessed by EuroQol-5 Dimension-5 Level (EQ5D-5L) 6 months after ED admission The 5-level EQ-5D version (EQ-5D-5L) score range was -0.148 (worst health state) to 0.949 (best health state). A higher score indicating a better health state.
Trial Locations
- Locations (25)
St. Mary's Hospital
🇬🇧London, United Kingdom
Royal Victoria Infirmary
🇬🇧Newcastle Upon Tyne, United Kingdom
Queens Medical Centre
🇬🇧Nottingham, United Kingdom
Royal Preston Hospital
🇬🇧Preston, United Kingdom
University Hospital Southampton
🇬🇧Southampton, United Kingdom
Salford Royal Hospital
🇬🇧Manchester, United Kingdom
Manchester Royal Infirmary
🇬🇧Manchester, United Kingdom
John Radcliffe Hospital
🇬🇧Oxford, United Kingdom
Derriford Hospital
🇬🇧Plymouth, United Kingdom
Northern General Hospital
🇬🇧Sheffield, United Kingdom
James Cook University Hospital
🇬🇧Middlesbrough, United Kingdom
University Hospital of North Staffordshire
🇬🇧Stoke-on-Trent, United Kingdom
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
University Hospital of Wales
🇬🇧Cardiff, 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
St. George's Hospital
🇬🇧London, United Kingdom
Southmead Hospital
🇬🇧Bristol, United Kingdom
Addenbrooke's Hospital
🇬🇧Cambridge, United Kingdom
University Hospital of Coventry and Warwickshire
🇬🇧Coventry, United Kingdom
King's College Hospital
🇬🇧London, United Kingdom