Trauma Resuscitation With Low-Titer Group O Whole Blood or Products
TROOP
2 other identifiers
interventional
1,100
1 country
13
Brief Summary
The goal of this clinical trial is to compare the effectiveness of unseparated whole blood (referred to as Low-Titer Group O Whole Blood) and the separate components of whole blood (including red cells, plasma, platelets, and cryoprecipitate) in critically injured patients who require large-volume blood transfusions.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 2023
Typical duration for phase_3
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 8, 2022
CompletedFirst Posted
Study publicly available on registry
December 6, 2022
CompletedStudy Start
First participant enrolled
July 27, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2027
August 21, 2025
August 1, 2025
3.4 years
November 8, 2022
August 15, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
6-hour Mortality
Participant vital status at 6-hours following randomization (randomization defined as product container is opened for administration to participant)
First 6 hours after randomization
Secondary Outcomes (12)
24-hour Mortality
First 24 hours after randomization
Hospital/30-day Mortality
From randomization to hospital discharge or 30-days post randomization (whichever the earlier)
Incidence of Pre-specified Complications
From randomization to hospital discharge or 30-days post randomization (whichever the earlier)
Adjudicated Primary Cause of Death
30-days post randomization
Length of Stay (Hospital and Intensive Care Unit)
From randomization to hospital discharge or 30-days post randomization (whichever the earlier)
- +7 more secondary outcomes
Study Arms (2)
LTOWB
ACTIVE COMPARATORParticipants randomized to receive (Low Titer O Whole Blood \[LTOWB\])
Components
ACTIVE COMPARATORParticipants randomized to receive the component blood products.
Interventions
Participants will receive Low Titer O Whole Blood administered intravenously or intraosseously.
Participants will receive separated blood components (i.e., units of red cells, plasma, platelets, and cryoprecipitate) co-administered intravenously or intraosseously.
Eligibility Criteria
You may qualify if:
- Adult trauma patient (estimated age \> 15 or weight \> 50 kg, if age unknown)
- Patient taken to trauma center directly from scene
- Commencement of blood transfusion (PRBC, plasma or LTOWB), in pre-hospital or in-hospital setting
- Activation of site-specific Massive Hemorrhage Protocol or Massive Transfusion Protocol
- Traumatic injury with at least one of the following:
- Confirmed or suspected acute major bleeding
- Assessment of Blood Consumption (ABC) Score ≥2
You may not qualify if:
- Patients who have received, prehospital or in-hospital more than two units of LTOWB; the equivalent in components (two units of packed red blood cells and two units of plasma); or a combination of the two (more than one unit of LTOWB, one unit of packed cells, and one unit of plasma). Most trauma centers hold two units of either packed red blood cells (with two units of plasma) or two units of LTOWB in the emergency department. This stock is used to initiate transfusion, while the massive hemorrhage protocol is activated from the blood bank.
- Patients transferred from another hospital
- Children \<15 years (in most communities, patients aged 15-18 years are treated at adult trauma centers, and patients in this age group frequently suffer life-threatening injuries, and will therefore be included)
- Known prisoners, defined as individuals involuntarily confined or detained in a penal institution (including juvenile detention, involuntary psychiatric commitment, or court-ordered residential substance abuse treatment)
- Moribund patients expected to die within 1 hour
- Patients who required an ED thoracotomy or received more than 5 consecutive minutes of cardiopulmonary resuscitation (prior to receiving randomized blood products)
- Patients with known "do not resuscitate" orders prior to randomization
- Patients who refuse the administration of blood products
- Individuals with a research "opt out" bracelet.
- Greater than 20% total body surface area (TBSA) burns
- Suspected inhalation injury victims
- Patients who are obviously pregnant on clinical examination or known to be pregnant as provided by the subject or legally authorized representative
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
University of Alabama at Birmingham, UAB Hospital
Birmingham, Alabama, 35294, United States
Los Angeles County + University of Southern California (LAC + USC) Medical Center
Los Angeles, California, 90033, United States
University Medical Center New Orleans LCMC Health
New Orleans, Louisiana, 70112, United States
University of Maryland Medical Center
Baltimore, Maryland, 21201, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, 27157, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, 45267, United States
Oregon Health and Sciences University Hospital
Portland, Oregon, 97239, United States
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104, United States
University of Texas Health Science Center Houston
Houston, Texas, 77030, United States
University of Texas Health San Antonio and University Health System
San Antonio, Texas, 78229, United States
Harborview Medical Center
Seattle, Washington, 98104, United States
Froedtert Hospital
Milwaukee, Wisconsin, 53226, United States
Related Publications (2)
Jansen JO, Pedroza C, Novelo LL, Hao T, DeWildt GR, Coton CF, Mansoor K, Stephens SW, Marques MB, Stubbs JR, Richter JR, Wang HE, Holcomb JB, DeSantis SM. Trauma resuscitation with Low-Titer Group O Whole Blood Or Products: study protocol for a randomized clinical trial (the TROOP trial). Trials. 2025 Aug 2;26(1):266. doi: 10.1186/s13063-025-08971-y.
PMID: 40753420DERIVEDMeizoso JP, Cotton BA, Lawless RA, Kodadek LM, Lynde JM, Russell N, Gaspich J, Maung A, Anderson C, Reynolds JM, Haines KL, Kasotakis G, Freeman JJ. Whole blood resuscitation for injured patients requiring transfusion: A systematic review, meta-analysis, and practice management guideline from the Eastern Association for the Surgery of Trauma. J Trauma Acute Care Surg. 2024 Sep 1;97(3):460-470. doi: 10.1097/TA.0000000000004327. Epub 2024 Mar 27.
PMID: 38531812DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jan Jansen, MBBS, PhD
University of Alabama at Birmingham
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- Care providers will be blinded to assignment until the point of randomization, which is when the cooler is opened, in the trauma bay, to remove blood products for transfusion.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 8, 2022
First Posted
December 6, 2022
Study Start
July 27, 2023
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
June 30, 2027
Last Updated
August 21, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share