Low-Titer O Positive Whole Blood Versus Component Therapy for Emergent Transfusion in Trauma Patients
Primary Purpose
Hemorrhagic Shock, Acute Blood Loss Anemia, Traumatic Brain Injury
Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Routine labs
Sponsored by
About this trial
This is an interventional treatment trial for Hemorrhagic Shock
Eligibility Criteria
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
Sites / Locations
- Loma Linda University HealthRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Low Titer O+ Whole Blood
Component Therapy
Arm Description
Low Titer O+ Whole blood provided to Level A trauma patients
Component Therapy of O+ pRBC and FFP dispatched to trauma bay for level A traumas
Outcomes
Primary Outcome Measures
pRBC equivalents transfused
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 Outcome Measures
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:
there is no evidence of arousal or awareness to maximal external stimuli
pupils are fixed in a midsized or dilated position and non reactive to light
corneal, oculocephalic and oculovestibular reflexes are absent
There is no facial movement to noxious stimuli
the gag reflex is absent to bilateral posterior pharyngeal stimuli
the cough reflex is absent to deep tracheal suctioning
there is no brain mediated motor response to noxious stimuli of the limbs
spontaneous respirations are not observed when apnea test targets reach pH <7.30 and PaCO2 >60mmhg
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05081063
Brief Title
Low-Titer O Positive Whole Blood Versus Component Therapy for Emergent Transfusion in Trauma Patients
Official Title
Low-Titer O Positive Whole Blood Versus Component Therapy for Emergent Transfusion in Trauma Patients
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 5, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Loma Linda University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Adult male patients brought to the emergency department as Level A trauma activations who are receiving emergency blood transfusion.
Objectives
Evaluate PRBC equivalents transfused in each group in the first 24 hours (Primary outcome)
Evaluate total transfusion in each group in the first 24 hours (Secondary Outcome) including breakdown by FFP equivalents, platelet units, and cryoprecipitate
Evaluate 6 hour, 24 hour, and hospital mortality (Secondary Outcome)
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
Evaluate PRBC equivalents transfused in each group in the first 24 hours (Primary outcome)
Evaluate total transfusion in each group in the first 24 hours (Secondary Outcome) including breakdown by FFP equivalents, platelet units, and cryoprecipitate
Evaluate 6 hour, 24 hour, and hospital mortality (Secondary Outcome)
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
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)
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemorrhagic Shock, Acute Blood Loss Anemia, Traumatic Brain Injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Adult male patients brought to the emergency department as Level A trauma activations who are receiving emergency blood transfusion
Masking
Participant
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Low Titer O+ Whole Blood
Arm Type
Experimental
Arm Description
Low Titer O+ Whole blood provided to Level A trauma patients
Arm Title
Component Therapy
Arm Type
Active Comparator
Arm Description
Component Therapy of O+ pRBC and FFP dispatched to trauma bay for level A traumas
Intervention Type
Combination Product
Intervention Name(s)
Routine labs
Intervention Description
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.
Primary Outcome Measure Information:
Title
pRBC equivalents transfused
Description
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
24 hours post ED admission
Secondary Outcome Measure Information:
Title
Mortality
Description
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:
there is no evidence of arousal or awareness to maximal external stimuli
pupils are fixed in a midsized or dilated position and non reactive to light
corneal, oculocephalic and oculovestibular reflexes are absent
There is no facial movement to noxious stimuli
the gag reflex is absent to bilateral posterior pharyngeal stimuli
the cough reflex is absent to deep tracheal suctioning
there is no brain mediated motor response to noxious stimuli of the limbs
spontaneous respirations are not observed when apnea test targets reach pH <7.30 and PaCO2 >60mmhg
Time Frame
Change between ED admission date and 24 hours post discharge
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anthony M Strada, MD
Phone
603-953-6795
Email
tonymstrada@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Kaushik Mukherjee, MD
Phone
909-558-4877
Email
kmukherjee@llu.edu
Facility Information:
Facility Name
Loma Linda University Health
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kaushik Mukherjee
Phone
909-558-1000
Ext
44286
Email
KMukherjee@llu.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31464874
Citation
Williams J, Merutka N, Meyer D, Bai Y, Prater S, Cabrera R, Holcomb JB, Wade CE, Love JD, Cotton BA. Safety profile and impact of low-titer group O whole blood for emergency use in trauma. J Trauma Acute Care Surg. 2020 Jan;88(1):87-93. doi: 10.1097/TA.0000000000002498.
Results Reference
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PubMed Identifier
33831229
Citation
Murphy C, Silva de Leonardi N. The use of low-titer group O whole blood is independently associated with improved survival compared to component therapy in adults with severe traumatic hemorrhage. Transfusion. 2021 Apr;61(4):1341-1342. doi: 10.1111/trf.16266. No abstract available.
Results Reference
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PubMed Identifier
30160310
Citation
Seheult JN, Anto V, Alarcon LH, Sperry JL, Triulzi DJ, Yazer MH. Clinical outcomes among low-titer group O whole blood recipients compared to recipients of conventional components in civilian trauma resuscitation. Transfusion. 2018 Aug;58(8):1838-1845. doi: 10.1111/trf.14779. Epub 2018 Aug 30.
Results Reference
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PubMed Identifier
32744830
Citation
Hanna K, Bible L, Chehab M, Asmar S, Douglas M, Ditillo M, Castanon L, Tang A, Joseph B. Nationwide analysis of whole blood hemostatic resuscitation in civilian trauma. J Trauma Acute Care Surg. 2020 Aug;89(2):329-335. doi: 10.1097/TA.0000000000002753.
Results Reference
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PubMed Identifier
23979267
Citation
Cotton BA, Podbielski J, Camp E, Welch T, del Junco D, Bai Y, Hobbs R, Scroggins J, Hartwell B, Kozar RA, Wade CE, Holcomb JB; Early Whole Blood Investigators. A randomized controlled pilot trial of modified whole blood versus component therapy in severely injured patients requiring large volume transfusions. Ann Surg. 2013 Oct;258(4):527-32; discussion 532-3. doi: 10.1097/SLA.0b013e3182a4ffa0. Erratum In: Ann Surg. 2014 Jul;260(1):178.
Results Reference
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Low-Titer O Positive Whole Blood Versus Component Therapy for Emergent Transfusion in Trauma Patients
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