Phase 3
N=1,604
Early Use of Cryoprecipitate With Major Hemorrhage Protocol (MHP) Activation
Trauma Injury
Bottom Line
View on ClinicalTrials.gov: NCT04704869 ↗Enrolled (actual)
1,604
Serious AEs
10.4%
Results posted
Feb 2023
Primary outcome: Primary: Number of Participants With Mortality From Any Cause — 201; 192 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Cryoprecipitate (Biological); Red Blood Cells (Biological); Plasma (Biological); Platelets (Biological); Whole Blood (Biological)
- Age
- Pediatric, Adult, Older Adult · 16+ yrs
- Sex
- All
- Sponsor
- Bryan Cotton
- Primary completion
- Dec 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Mortality From Any Cause |
201; 192 | — |
| SECONDARY All Cause Mortality at 6 Hours |
56; 68 | — |
| SECONDARY All Cause Mortality at 24 Hours |
88; 97 | — |
| SECONDARY All Cause Mortality at 6 Months |
26.1; 27.3 | — |
| SECONDARY All Cause Mortality at 12 Months |
26.6; 27.7 | — |
| SECONDARY Death From Bleeding at 6 Hours |
32; 35 | — |
| SECONDARY Death From Bleeding at 24 Hours |
43; 39 | — |
| SECONDARY Transfusion Requirements (Number of Units of Red Blood Cells (RBCs)) |
5; 5 | — |
| SECONDARY Transfusion Requirements (Number of Units of Plasma) |
4; 4 | — |
| SECONDARY Transfusion Requirements (Number of Units of Platelets) |
0; 0 | — |
| SECONDARY Transfusion Requirements (Number of Units of Cryoprecipitate) |
3; 0 | — |
| SECONDARY Destination of Participant at Time of Discharge From Hospital |
280; 278; 9; 8; 63; 72 | — |
| SECONDARY Quality of Life as Assessed by EuroQol-5 Dimension-5 Level (EQ5D-5L) |
0.76; 0.66 | — |
| SECONDARY Quality of Life as Assessed by the Glasgow Outcome Score |
— | — |
| SECONDARY Quality of Life as Assessed by EuroQol-5 Dimension-5 Level (EQ5D-5L) |
0.76; 0.66 | — |
| SECONDARY Quality of Life as Assessed by the Glasgow Outcome Score |
— | — |
| SECONDARY Hospital Resource Use as Assessed by Number of Ventilator Days |
1; 1 | — |
| SECONDARY Hospital Resource Use as Assessed by Number of Intensive Care Unit (ICU) Days |
4; 4 | — |
| SECONDARY Hospital Resource Use as Assessed by Number of Hospital Days |
11; 11 | — |
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).
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04704869). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.