Trauma Injury
Conditions
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).
Interventions
BIOLOGICALCryoprecipitate
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).
BIOLOGICALRed Blood Cells
RBCs are utilized as part of the Massive Transfusion protocol for hemorrhage control.
BIOLOGICALPlasma
Plasma is utilized as part of the Massive Transfusion protocol for hemorrhage control.
BIOLOGICALPlatelets
Platelets are utilized as part of the Massive Transfusion protocol for hemorrhage control.
BIOLOGICALWhole Blood
Whole Blood is utilized as part of the Massive Transfusion protocol for hemorrhage control.
Sponsors
Queen Mary University of London
NHS Blood and Transplant
Bryan Cotton
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Mortality From Any Cause | 28 days after emergency department (ED) admission | Mortality from any cause |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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 |
| 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 Plasma) | from time of pre-hospital care to 24 hours after ED admission, an average of 30 hours | Number of units of plasma |
| 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 |
| All Cause Mortality at 24 Hours | 24 hours after ED admission | Mortality from any cause |
| 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) | Day of hospital discharge or 28 days after ED admission (whichever comes first) | 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. |
| All Cause Mortality at 6 Hours | 6 hours after ED admission | Mortality from any cause |
| Quality of Life as Assessed by the Glasgow Outcome Score | Day of hospital discharge or 28 days after ED admission (whichever comes first) | 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 deficits |
| Hospital 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 |
| 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 Cryoprecipitate) | from time of pre-hospital care to 24 hours after ED admission, an average of 30 hours | Number of units of cryoprecipitate |
Countries
United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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).
Cryoprecipitate: 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).
Red Blood Cells: RBCs are utilized as part of the Massive Transfusion protocol for hemorrhage control.
Plasma: Plasma is utilized as part of the Massive Transfusion protocol for hemorrhage control.
Platelets: Platelets are utilized as part of the Massive Transfusion protocol for hemorrhage control.
Whole Blood: Whole Blood is utilized as part of the Massive Transfusion protocol for hemorrhage control. | 799 |
| 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.
Red Blood Cells: RBCs are utilized as part of the Massive Transfusion protocol for hemorrhage control.
Plasma: Plasma is utilized as part of the Massive Transfusion protocol for hemorrhage control.
Platelets: Platelets are utilized as part of the Massive Transfusion protocol for hemorrhage control.
Whole Blood: Whole Blood is utilized as part of the Massive Transfusion protocol for hemorrhage control. | 805 |
| Total | 1,604 |
Baseline characteristics
| Characteristic | Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) | Total | Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) |
|---|---|---|---|
| Age, Continuous | 38 years | 39 years | 40 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 16 Participants | 30 Participants | 14 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 8 Participants | 17 Participants | 9 Participants |
| Number of Participants who arrived at the Emergency Department with a blunt injury | 495 Participants | 1014 Participants | 519 Participants |
| Number of Participants who arrived to the Emergency Department in cardiac arrest | 12 Participants | 29 Participants | 17 Participants |
| Race/Ethnicity, Customized Race Black | 10 Participants | 16 Participants | 6 Participants |
| Race/Ethnicity, Customized Race Other | 9 Participants | 19 Participants | 10 Participants |
| Race/Ethnicity, Customized Race White | 5 Participants | 13 Participants | 8 Participants |
| Region of Enrollment United Kingdom | 775 participants | 1555 participants | 780 participants |
| Region of Enrollment United States | 24 participants | 48 participants | 25 participants |
| Sex: Female, Male Female | 167 Participants | 330 Participants | 163 Participants |
| Sex: Female, Male Male | 618 Participants | 1251 Participants | 633 Participants |
| Time from injury to ED arrival | 75 minutes | 76 minutes | 77 minutes |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 201 / 771 | 192 / 760 |
| other Total, other adverse events | 0 / 805 | 0 / 799 |
| serious Total, serious adverse events | 83 / 805 | 84 / 799 |
Outcome results
Primary
Number of Participants With Mortality From Any Cause
Mortality from any cause
Time frame: 28 days after emergency department (ED) admission
Population: Vital status was not available from any source for 34 in the Massive Transfusion Protocol arm and 39 in the Early Cryoprecipitate plus Massive Transfusion Protocol arm. Data presented are from an intention to treat analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) | Number of Participants With Mortality From Any Cause | 201 Participants |
| Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) | Number of Participants With Mortality From Any Cause | 192 Participants |
95% CI: [0.81, 1.17]
Secondary
All Cause Mortality at 12 Months
Mortality from any cause. All cause mortality at 6 months is presented as a Kaplan-Meier estimated.
Time frame: 12 months after ED admission
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) | All Cause Mortality at 12 Months | 26.6 percentage of participants |
| Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) | All Cause Mortality at 12 Months | 27.7 percentage of participants |
Secondary
All Cause Mortality at 24 Hours
Mortality from any cause
Time frame: 24 hours after ED admission
Population: Data were not collected for 16 participants in the Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm. Data were not collected for 11 participants in the Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) | All Cause Mortality at 24 Hours | 88 Participants |
| Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) | All Cause Mortality at 24 Hours | 97 Participants |
Secondary
All Cause Mortality at 6 Hours
Mortality from any cause
Time frame: 6 hours after ED admission
Population: Data were not collected for 15 participants in the Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm. Data were not collected for 10 participants in the Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) | All Cause Mortality at 6 Hours | 56 Participants |
| Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) | All Cause Mortality at 6 Hours | 68 Participants |
Secondary
All Cause Mortality at 6 Months
Mortality from any cause. All cause mortality at 6 months is presented as a Kaplan-Meier estimated.
Time frame: 6 months after ED admission
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) | All Cause Mortality at 6 Months | 26.1 percentage of participants |
| Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) | All Cause Mortality at 6 Months | 27.3 percentage of participants |
Secondary
Death From Bleeding at 24 Hours
Death related to exsanguination
Time frame: 24 hours after ED admission
Population: Data were not collected from 11 participants in the Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm. Data were not collected from 16 participants in the Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) | Death From Bleeding at 24 Hours | 43 Participants |
| Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) | Death From Bleeding at 24 Hours | 39 Participants |
Secondary
Death From Bleeding at 6 Hours
Death related to exsanguination
Time frame: 6 hours after ED admission
Population: Data were not collected from 10 participants in the Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm. Data were not collected from 15 participants in the Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) | Death From Bleeding at 6 Hours | 32 Participants |
| Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) | Death From Bleeding at 6 Hours | 35 Participants |
Secondary
Destination of Participant at Time of Discharge From Hospital
Destination of participant at time of discharge from hospital
Time frame: at the time of discharge from hospital, about 11-27 days after admission
Population: Data were not collected from 431 participants in the Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm. Data were not collected from 424 participants in the Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) | Destination of Participant at Time of Discharge From Hospital | Other hospital | 63 Participants |
| Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) | Destination of Participant at Time of Discharge From Hospital | Home | 280 Participants |
| Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) | Destination of Participant at Time of Discharge From Hospital | Other | 23 Participants |
| Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) | Destination of Participant at Time of Discharge From Hospital | Nursing home/rehabilitation facility | 9 Participants |
| Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) | Destination of Participant at Time of Discharge From Hospital | Other | 16 Participants |
| Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) | Destination of Participant at Time of Discharge From Hospital | Other hospital | 72 Participants |
| Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) | Destination of Participant at Time of Discharge From Hospital | Nursing home/rehabilitation facility | 8 Participants |
| Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) | Destination of Participant at Time of Discharge From Hospital | Home | 278 Participants |
Secondary
Hospital Resource Use as Assessed by Number of Hospital Days
Total number of hospital days
Time frame: Day of hospital discharge or 28 days after ED admission (whichever comes first)
Population: Data were not collected from 33 participants in the Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm. Data were not collected from 36 participants in the Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) | Hospital Resource Use as Assessed by Number of Hospital Days | 11 days |
| Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) | Hospital Resource Use as Assessed by Number of Hospital Days | 11 days |
Secondary
Hospital Resource Use as Assessed by Number of Intensive Care Unit (ICU) Days
Number of ICU days during hospitalization
Time frame: Day of hospital discharge or 28 days after ED admission (whichever comes first)
Population: Data were not collected from 34 participants in the Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm. Data were not collected from 36 participants in the Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) | Hospital Resource Use as Assessed by Number of Intensive Care Unit (ICU) Days | 4 days |
| Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) | Hospital Resource Use as Assessed by Number of Intensive Care Unit (ICU) Days | 4 days |
Secondary
Hospital Resource Use as Assessed by Number of Ventilator Days
Number of ventilator days during hospitalization
Time frame: Day of hospital discharge or 28 days after ED admission (whichever comes first)
Population: Data were not collected from 34 participants in the Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm. Data were not collected from 36 participants in the Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) | Hospital Resource Use as Assessed by Number of Ventilator Days | 1 days |
| Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) | Hospital Resource Use as Assessed by Number of Ventilator Days | 1 days |
Secondary
Quality of Life as Assessed by EuroQol-5 Dimension-5 Level (EQ5D-5L)
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.
Time frame: Day of hospital discharge or 28 days after ED admission (whichever comes first)
Population: Data were not collected from 458 participants in the Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm. Data were not collected from 475 participants in the Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) | Quality of Life as Assessed by EuroQol-5 Dimension-5 Level (EQ5D-5L) | 0.51 score on a scale |
| Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) | Quality of Life as Assessed by EuroQol-5 Dimension-5 Level (EQ5D-5L) | 0.50 score on a scale |
Secondary
Quality of Life as Assessed by EuroQol-5 Dimension-5 Level (EQ5D-5L)
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.
Time frame: 6 months after ED admission
Population: Data were not collected from 350 participants in the Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm. Data were not collected from 331 participants in the Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) | Quality of Life as Assessed by EuroQol-5 Dimension-5 Level (EQ5D-5L) | 0.76 score on a scale |
| Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) | Quality of Life as Assessed by EuroQol-5 Dimension-5 Level (EQ5D-5L) | 0.66 score on a scale |
Secondary
Quality of Life as Assessed by the Glasgow Outcome Score
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 deficits
Time frame: Day of hospital discharge or 28 days after ED admission (whichever comes first)
Population: Data were not collected from 93 participants in the Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm. Data were not collected from 94 participants in the Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) | Quality of Life as Assessed by the Glasgow Outcome Score | Low disability | 226 Participants |
| Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) | Quality of Life as Assessed by the Glasgow Outcome Score | Persistent vegetative state | 21 Participants |
| Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) | Quality of Life as Assessed by the Glasgow Outcome Score | Severe disability | 155 Participants |
| Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) | Quality of Life as Assessed by the Glasgow Outcome Score | Death | 174 Participants |
| Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) | Quality of Life as Assessed by the Glasgow Outcome Score | Moderate disability | 129 Participants |
| Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) | Quality of Life as Assessed by the Glasgow Outcome Score | Death | 182 Participants |
| Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) | Quality of Life as Assessed by the Glasgow Outcome Score | Low disability | 221 Participants |
| Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) | Quality of Life as Assessed by the Glasgow Outcome Score | Moderate disability | 129 Participants |
| Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) | Quality of Life as Assessed by the Glasgow Outcome Score | Severe disability | 153 Participants |
| Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) | Quality of Life as Assessed by the Glasgow Outcome Score | Persistent vegetative state | 27 Participants |
Secondary
Quality of Life as Assessed by the Glasgow Outcome Score
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 deficits
Time frame: 6 months after ED admission
Population: Data for this outcome measure were not collected because the survey was not included on the 6-month follow-up. As a result, no participants received the survey, and therefore, no participants were analyzed in either study arm.
Secondary
Transfusion Requirements (Number of Units of Cryoprecipitate)
Number of units of cryoprecipitate
Time frame: from time of pre-hospital care to 24 hours after ED admission, an average of 30 hours
Population: Data were not collected from 110 participants in the Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm. Data were not collected from 104 participants in the Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) | Transfusion Requirements (Number of Units of Cryoprecipitate) | 3 Units |
| Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) | Transfusion Requirements (Number of Units of Cryoprecipitate) | 0 Units |
Secondary
Transfusion Requirements (Number of Units of Plasma)
Number of units of plasma
Time frame: from time of pre-hospital care to 24 hours after ED admission, an average of 30 hours
Population: Data were not collected from 108 participants in the Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm. Data were not collected from 104 participants in the Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) | Transfusion Requirements (Number of Units of Plasma) | 4 units |
| Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) | Transfusion Requirements (Number of Units of Plasma) | 4 units |
Secondary
Transfusion Requirements (Number of Units of Platelets)
Number of units of platelets
Time frame: from time of pre-hospital care to 24 hours after ED admission, an average of 30 hours
Population: Data were not collected from 110 participants in the Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm. Data were not collected from 104 participants in the Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) | Transfusion Requirements (Number of Units of Platelets) | 0 Units |
| Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) | Transfusion Requirements (Number of Units of Platelets) | 0 Units |
Secondary
Transfusion Requirements (Number of Units of Red Blood Cells (RBCs))
Number of units of RBCs
Time frame: from time of pre-hospital care to 24 hours after ED admission, an average of 30 hours
Population: Data were not collected from 108 participants in the Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm. Data were not collected from 104 participants in the Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) | Transfusion Requirements (Number of Units of Red Blood Cells (RBCs)) | 5 Units |
| Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) | Transfusion Requirements (Number of Units of Red Blood Cells (RBCs)) | 5 Units |