Wounds and InjuriesPhase 3TROOPNCT05638581
Trauma Resuscitation With Low-Titer Group O Whole Blood or Products
A Phase 3 study testing LTOWB and Components in people with Wounds and Injuries and Shock, Hemorrhagic, run by University of Alabama at Birmingham at 13 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Wounds and Injuries, Shock, Hemorrhagic
- What is being tested?
- LTOWB and Components
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,100 participants
- Where
- 13 sitesUnited States
- Study dates
- 27 Jul 2023to 4 Aug 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 12Show fewer
- 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
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
University of Maryland Medical Center
Baltimore, Maryland, 21201
University of Alabama at Birmingham, UAB Hospital
Birmingham, Alabama, 35294
University of Cincinnati Medical Center
Cincinnati, Ohio, 45267
University of Texas Health Science Center Houston
Houston, Texas, 77030
Los Angeles County + University of Southern California (LAC + USC) Medical Center
Los Angeles, California, 90033
Froedtert Hospital
Milwaukee, Wisconsin, 53226
University Medical Center New Orleans LCMC Health
New Orleans, Louisiana, 70112
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104
Oregon Health and Sciences University Hospital
Portland, Oregon, 97239
University of Texas Health San Antonio and University Health System
San Antonio, Texas, 78229
Harborview Medical Center
Seattle, Washington, 98104
Washington University School of Medicine
St Louis, Missouri, 63110
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, 27157
About this study
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.
Read the detailed description
Trauma is one of the leading causes of death in the United States, and disproportionately affects the young, killing those who might otherwise have lived long and productive lives. Injuries account for more years of potential life lost before age 75 than any other cause. Hemorrhage remains the most common cause of preventable death after injury, and blood transfusion is an essential part of treatment. Modern blood banking practices separate donated whole blood into components. The current standard of care in trauma transfusion is the balanced administration of equal numbers of units of blood components (packed red blood cells, plasma, and platelets), effectively attempting to reconstitute whole blood. A renewed approach to blood transfusion therapy in trauma is to use whole blood from the outset, which has not been separated. Compared with component therapy, whole blood offers several potential advantages, but there are only a small number of, mostly observational, studies comparing whole blood and component therapy, and they are very heterogeneous.
The TROOP trial will include injured adults with hemorrhagic shock anticipated to require massive blood transfusions, who will be randomized to receive either whole blood (LTOWB) or blood components. This will allow a direct comparison to see if one type of transfusion is more strongly associated with improved clinical outcomes over the other.
The knowledge gained from this clinical trial will transform the way in which massively bleeding trauma patients are transfused. The trial is exceedingly well positioned to improve mortality from trauma and reduce the number of preventable deaths resulting from hemorrhagic shock.
- Conditions
- Wounds and Injuries, Shock, Hemorrhagic
- Being tested
- LTOWB, Components
- Keywords
- Massive Transfusion, Trauma, Shock, Hemorrhage, Plasma, Platelets, Red Blood Cells, Low-Titer Group O Whole Blood, Blood components
- Medical subject headings
- Wounds and Injuries, Shock, Hemorrhagic, Shock, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LTOWBBiological
Participants will receive Low Titer O Whole Blood administered intravenously or intraosseously.
ComponentsBiological
Participants will receive separated blood components (i.e., units of red cells, plasma, platelets, and cryoprecipitate) co-administered intravenously or intraosseously.
| Study group | Role | What they receive |
|---|---|---|
| LTOWB | Active comparator | Participants randomized to receive (Low Titer O Whole Blood [LTOWB]) Receives: Biological: LTOWB |
| Components | Active comparator | Participants randomized to receive the component blood products. Receives: Biological: Components |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-hour Mortality
Participant vital status at 6-hours following randomization (randomization defined as product container is opened for administration to participant)
Measured: First 6 hours after randomization
Secondary outcomes (12)
24-hour Mortality
Participant vital status at 24-hours following randomization
Measured: First 24 hours after randomization
Hospital/30-day Mortality
Participant vital status at hospital discharge or 30-days post randomization (whichever the earlier)
Measured: From randomization to hospital discharge or 30-days post randomization (whichever the earlier)
Incidence of Pre-specified Complications
The number of participants experiencing pre-specified complications. Pre-specified complications include: Acute kidney injury; Ventilator-associated pneumonia; Multiorgan failure; Transfusion-related hyperkalemia; Transfusion-related hypocalcemia; Transfusion associated circulatory overload; Acute respiratory distress syndrome; Symptomatic and asymptomatic deep vein thrombosis; Symptomatic and asymptomatic pulmonary embolism; Bleeding after hemostasis requiring intervention; Stroke; Myocardial infarction; Abdominal compartment syndrome; Transfusion-related allergic reactions; Febrile non-hemolytic transfusion reaction; Systemic inflammatory response syndrome; Sepsis; Alloimmunization in women of childbearing age
Measured: From randomization to hospital discharge or 30-days post randomization (whichever the earlier)
Adjudicated Primary Cause of Death
Primary cause of death as reviewed and determined by the study investigators (consensus)
Measured: 30-days post randomization
Length of Stay (Hospital and Intensive Care Unit)
Number of hours hospitalized (includes both hospital and intensive care unit time)
Measured: From randomization to hospital discharge or 30-days post randomization (whichever the earlier)
Hospital-, Ventilator- and Intensive Care Unit-free days
Number of days participant was alive and out of the hospital; number of days participant was not on a ventilator; and the number of days the participant was not in the intensive care unit.
Measured: 30-days post randomization
Incidence of major surgical procedures
The proportion of participants undergoing major surgical procedures.
Measured: From randomization to hospital discharge or 30-days post randomization (whichever the earlier)
Time to hemostasis in those undergoing procedures with a hemostatic component
Time to hemostasis refers to the time that the subject achieved hemorrhage control (anatomic hemostasis and resuscitation complete) following emergency department arrival.
Measured: From randomization to hospital discharge or 30-days post randomization (whichever the earlier)
Number and type of blood products used until hemostasis is achieved and from hemostasis to 24 hours after randomization
The number of units and type of blood products (e.g. whole blood, packed red blood cells, platelets, plasma, etc.)
Measured: First 24 hours after randomization
Discharge destination
Discharge destination will be measured as a categorical variable. Categories will be tallied and compared between the two study arms. Example variables include: discharged to home, discharged to another primary care facility, discharged to hospice, etc.
Measured: At hospital discharge or 30-days post randomization (whichever the earlier)
Functional status
Functional status will be measured by Extended Glasgow Outcome Scale (GOSE). The GOSE is a tool used to measure recovery following brain injury and assists with prediction of long-term rehabilitation. The 8 scoring categories are death, vegetative state, lower severe disability, upper severe disability, lower moderate disability, upper moderate disability, lower good recovery and upper good recovery. A higher GOSE score correlates with better outcome.
Measured: From randomization to hospital discharge or 30-days post randomization (whichever the earlier)
Patient's quality of life
Quality of life will be measured by the Euroqol Group's EQ-5D quality of life measurement. The EQ-5D is a patient-reported questionnaire assessing health status in terms of five dimensions of health (mobility, self-care, usual activities, pain and discomfort, and anxiety and depression). Lower EQ-5D scores are associated with better outcome.
Measured: From randomization to hospital discharge or 30-days post randomization (whichever the earlier)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2022
- Study start27 Jul 2023
- Primary completion4 Aug 2026
- Study completion4 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Wounds and InjuriesStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 1,100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), The University of Texas Health Science Center, Houston
- Responsible party
- Principal investigator, Jan O. Jansen, University of Alabama at Birmingham
- Investigators
- Jan Jansen, MBBS, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05638581
- Sponsor's protocol ID
- IRB-300010517
- Other IDs
- 1UG3HL157401-01A1, 1U24HL157310-01A1
- Acronym
- TROOP
- Status last verified
- Aug 2026
- First submitted
- 8 Nov 2022
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40753420Meizoso 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.
PubMed 38531812
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trauma Resuscitation With Low-Titer Group O Whole Blood or Products
- ClinicalTrials.gov ID
- NCT05638581
- Acronym / sponsor ID
- TROOP / IRB-300010517
- Conditions
- Wounds and Injuries, Shock, Hemorrhagic
- Keywords
- Massive Transfusion, Trauma, Shock, Hemorrhage, Plasma, Platelets, Red Blood Cells, Low-Titer Group O Whole Blood
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,100 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), The University of Texas Health Science Center, Houston
- Study start
- 27 Jul 2023 (actual)
- Primary completion
- 4 Aug 2026 (actual)
- Study completion
- 4 Aug 2026 (actual)
- First posted
- 6 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Trauma is one of the leading causes of death in the United States, and disproportionately affects the young, killing those who might otherwise have lived long and productive lives. Injuries account for more years of potential life lost before age 75 than any other cause. Hemorrhage remains the most common cause of preventable death after injury, and blood transfusion is an essential part of treatment. Modern blood banking practices separate donated whole blood into components. The current standard of care in trauma transfusion is the balanced administration of equal numbers of units of blood components (packed red blood cells, plasma, and platelets), effectively attempting to reconstitute whole blood. A renewed approach to blood transfusion therapy in trauma is to use whole blood from the outset, which has not been separated. Compared with component therapy, whole blood offers several potential advantages, but there are only a small number of, mostly observational, studies comparing whole blood and component therapy, and they are very heterogeneous.
The TROOP trial will include injured adults with hemorrhagic shock anticipated to require massive blood transfusions, who will be randomized to receive either whole blood (LTOWB) or blood components. This will allow a direct comparison to see if one type of transfusion is more strongly associated with improved clinical outcomes over the other.
The knowledge gained from this clinical trial will transform the way in which massively bleeding trauma patients are transfused. The trial is exceedingly well positioned to improve mortality from trauma and reduce the number of preventable deaths resulting from hemorrhagic shock.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LTOWB | Active comparator | Biological: LTOWBParticipants randomized to receive (Low Titer O Whole Blood [LTOWB]) |
| Components | Active comparator | Biological: ComponentsParticipants randomized to receive the component blood products. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LTOWBParticipants will receive Low Titer O Whole Blood administered intravenously or intraosseously. | Biological | LTOWB |
| ComponentsParticipants will receive separated blood components (i.e., units of red cells, plasma, platelets, and cryoprecipitate) co-administered intravenously or intraosseously. | Biological | Components |
Primary outcome
6-hour Mortality
Time frame: First 6 hours after randomization
Participant vital status at 6-hours following randomization (randomization defined as product container is opened for administration to participant)
12 secondary outcomes
24-hour Mortality
Time frame: First 24 hours after randomization
Hospital/30-day Mortality
Time frame: From randomization to hospital discharge or 30-days post randomization (whichever the earlier)
Incidence of Pre-specified Complications
Time frame: From randomization to hospital discharge or 30-days post randomization (whichever the earlier)
Adjudicated Primary Cause of Death
Time frame: 30-days post randomization
Length of Stay (Hospital and Intensive Care Unit)
Time frame: From randomization to hospital discharge or 30-days post randomization (whichever the earlier)
Hospital-, Ventilator- and Intensive Care Unit-free days
Time frame: 30-days post randomization
Incidence of major surgical procedures
Time frame: From randomization to hospital discharge or 30-days post randomization (whichever the earlier)
Time to hemostasis in those undergoing procedures with a hemostatic component
Time frame: From randomization to hospital discharge or 30-days post randomization (whichever the earlier)
Number and type of blood products used until hemostasis is achieved and from hemostasis to 24 hours after randomization
Time frame: First 24 hours after randomization
Discharge destination
Time frame: At hospital discharge or 30-days post randomization (whichever the earlier)
Functional status
Time frame: From randomization to hospital discharge or 30-days post randomization (whichever the earlier)
Patient's quality of life
Time frame: From randomization to hospital discharge or 30-days post randomization (whichever the earlier)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Derived from this study: PubMed 40753420Jansen 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.
- Derived from this study: PubMed 38531812Meizoso 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.
- TROOP Consortium websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Jansen, MBBS, PhD principal investigator
University of Alabama at Birmingham
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing LTOWB and Components in people with Wounds and Injuries and Shock, Hemorrhagic, run by University of Alabama at Birmingham at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-hour Mortality (time frame: First 6 hours after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05638581, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.