Acute Blood Loss Anemia, Hemorrhagic Shock, Traumatic Brain Injury
Conditions
Brief summary
Adult male patients brought to the emergency department as Level A trauma activations who are receiving emergency blood transfusion. Objectives 1. Evaluate PRBC equivalents transfused in each group in the first 24 hours (Primary outcome) 2. Evaluate total transfusion in each group in the first 24 hours (Secondary Outcome) including breakdown by FFP equivalents, platelet units, and cryoprecipitate 3. Evaluate 6 hour, 24 hour, and hospital mortality (Secondary Outcome) 4. Evaluate ICU outcomes in each group
Detailed description
Based on the results from Cotton et al, median transfusion in the component therapy group was 6 PRBC in the first 24 hours and 4 PRBC equivalents in the whole blood group. The standard deviation (estimated from the interquartile range) was approximately 4. Thus with an expectation of alpha = 0.05 and expected power of 90% to detect a similar 2 unit difference in transfusion volume, a sample size of 190 should be sufficient; thus projected sample size of 200 should be more than adequate. Age range will be 18 years and older, and only males will be included in the study. Expected racial/ethnic distribution will be approximately 60% white, 15% black, 8% Asian, and 18% other race. No actual recruitment will be performed; rather all qualifying patients will be included. Consent waiver is being requested. b. Objectives 1. Evaluate PRBC equivalents transfused in each group in the first 24 hours (Primary outcome) 2. Evaluate total transfusion in each group in the first 24 hours (Secondary Outcome) including breakdown by FFP equivalents, platelet units, and cryoprecipitate 3. Evaluate 6 hour, 24 hour, and hospital mortality (Secondary Outcome) 4. Evaluate ICU outcomes in each group: 1\. ICU length of stay 2. Ventilator days 3. SOFA score on day of ICU discharge 4. Presence of ARDS 5. Presence of TRALI 6. Presence of DVT/PE 7. Necessity for Dialysis 8. Necessity for Tracheostomy 9. Evaluate viscoelastic testing parameters in both groups when sent on arrival in ICU 1\. Percentage of patients with EXTEM clotting time \> 80 sec 2. Percentage of patients with EXTEM amplitude at 10 min \< 40mm and FIBTEM amplitude at 10 min ≤ 10mm 3. Percentage of patients with EXTEM amplitude at 10 min \< 40mm and FIBTEM amplitude at 10 min \> 10mm 4. Percentage of patients with maximum thrombolysis \> 15% 5. Interval analyses to be performed after 6 and 12 months with provision to continue the study out to 24 months. 1\. Stopping rule: A statistically significant difference in hospital mortality at 6 months or 12 months 1. If in favor of LTOWB, consideration of trial termination and making LTOWB the primary standard of care for all trauma patients receiving emergency transfusion except for child-bearing age females (unless Rh immunoglobulin can be administered) 2. If in favor of component therapy, consideration of trial termination and making component therapy the primary standard care for all trauma patients receiving emergency transfusion
Interventions
COMBINATION_PRODUCTRoutine labs
Routine labs will be performed with CBC, BMP, Fox screen, ROTEM viscoelastic test, PT/INR, PTT and venous lactate for standard of care for all patients.
Sponsors
Loma Linda University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
Adult male patients brought to the emergency department as Level A trauma activations who are receiving emergency blood transfusion
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* all adult male patients brought into the emergency department as LEVEL A trauma activations who are receiving emergency blood transfusions
Exclusion criteria
* Female patients (specifically excluded due to risk of alloimmunization of Rh-negative female patients of childbearing age against Rh-positive blood) * children * prisoners * all patients classified as dead upon arrival to the trauma bay
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Packed Red Blood Cells Equivalents Units Transfused (1 Whole Blood Unit Treated as 1 Packed Red Blood Cell Unit and 1 Fresh Frozen Plasma Unit) | The total transfusion requirement of packed red blood cells was analyzed for the duration of the inpatient hospitalization for patients surviving at least 24 hours. This time is defined as a time period up to 30 days. | assessment of pRBC equivalents transfused in each arm, an increase in HGB by 1g/dl per unit transfused will be considered successful A blood draw of 5ml will be obtained and tested to assess HGB level. An increase in HGB by 1g/dl per unit transfused will be considered a successful result. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mortality | In patients surviving at least 24 hours who were included in analysis of outcome measures, we assessed survival to hospital discharge. This means the duration of time in the hospital up to discharge with a maximum of 30 days. | Assessment of mortality This is a composite measurement which includes the following in order to be assessed as pulseless with no respiratory drive or brain death: 1. there is no evidence of arousal or awareness to maximal external stimuli 2. pupils are fixed in a midsized or dilated position and non reactive to light 3. corneal, oculocephalic and oculovestibular reflexes are absent 4. There is no facial movement to noxious stimuli 5. the gag reflex is absent to bilateral posterior pharyngeal stimuli 6. the cough reflex is absent to deep tracheal suctioning 7. there is no brain mediated motor response to noxious stimuli of the limbs 8. spontaneous respirations are not observed when apnea test targets reach pH \<7.30 and PaCO2 \>60mmhg |
Countries
United States
Participant flow
Recruitment details
Male highest-tier trauma activations randomized in 24 hour blocks
Participants by arm
| Arm | Count |
|---|---|
| Low Titer O+ Whole Blood Low Titer O+ Whole blood provided to Level A trauma patients | 52 |
| Component Therapy Component Therapy of O+ pRBC and FFP dispatched to trauma bay for level A traumas | 147 |
| Total | 199 |
Baseline characteristics
| Characteristic | Low Titer O+ Whole Blood | Component Therapy | Total |
|---|---|---|---|
| Age, Continuous | 39.9 years STANDARD_DEVIATION 13.6 | 42.1 years STANDARD_DEVIATION 16.9 | 41.5 years STANDARD_DEVIATION 16.1 |
| First systolic blood pressure in ED | 91.2 mm Hg STANDARD_DEVIATION 50.4 | 98.4 mm Hg STANDARD_DEVIATION 44.6 | 96.5 mm Hg STANDARD_DEVIATION 46.2 |
| Glasgow Coma Scale in ED | 13.5 units on a scale | 14.0 units on a scale | 14 units on a scale |
| Injury severity score | 19.6 units on a scale STANDARD_DEVIATION 11.7 | 19.3 units on a scale STANDARD_DEVIATION 12.2 | 19.4 units on a scale STANDARD_DEVIATION 12 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 52 Participants | 147 Participants | 199 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 17 / 52 | 37 / 147 |
| other Total, other adverse events | 0 / 52 | 0 / 147 |
| serious Total, serious adverse events | 0 / 52 | 0 / 147 |
Outcome results
Primary
Packed Red Blood Cells Equivalents Units Transfused (1 Whole Blood Unit Treated as 1 Packed Red Blood Cell Unit and 1 Fresh Frozen Plasma Unit)
assessment of pRBC equivalents transfused in each arm, an increase in HGB by 1g/dl per unit transfused will be considered successful A blood draw of 5ml will be obtained and tested to assess HGB level. An increase in HGB by 1g/dl per unit transfused will be considered a successful result.
Time frame: The total transfusion requirement of packed red blood cells was analyzed for the duration of the inpatient hospitalization for patients surviving at least 24 hours. This time is defined as a time period up to 30 days.
Population: Population of patients surviving 24 hours analyzed for transfusion measures
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low Titer O+ Whole Blood | Packed Red Blood Cells Equivalents Units Transfused (1 Whole Blood Unit Treated as 1 Packed Red Blood Cell Unit and 1 Fresh Frozen Plasma Unit) | 3.8 units | Standard Deviation 5.6 |
| Component Therapy | Packed Red Blood Cells Equivalents Units Transfused (1 Whole Blood Unit Treated as 1 Packed Red Blood Cell Unit and 1 Fresh Frozen Plasma Unit) | 5.7 units | Standard Deviation 6.2 |
Secondary
Mortality
Assessment of mortality This is a composite measurement which includes the following in order to be assessed as pulseless with no respiratory drive or brain death: 1. there is no evidence of arousal or awareness to maximal external stimuli 2. pupils are fixed in a midsized or dilated position and non reactive to light 3. corneal, oculocephalic and oculovestibular reflexes are absent 4. There is no facial movement to noxious stimuli 5. the gag reflex is absent to bilateral posterior pharyngeal stimuli 6. the cough reflex is absent to deep tracheal suctioning 7. there is no brain mediated motor response to noxious stimuli of the limbs 8. spontaneous respirations are not observed when apnea test targets reach pH \<7.30 and PaCO2 \>60mmhg
Time frame: In patients surviving at least 24 hours who were included in analysis of outcome measures, we assessed survival to hospital discharge. This means the duration of time in the hospital up to discharge with a maximum of 30 days.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Low Titer O+ Whole Blood | Mortality | 4 Participants |
| Component Therapy | Mortality | 13 Participants |