Trauma Resuscitation With Low-Titer Group O Whole Blood or Products

Phase 3RecruitingNCT05638581

University of Alabama at Birmingham1,100 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

1,100

Conditions

Wounds and Injuries Shock, Hemorrhagic

Interventions

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.

Eligibility

Sex: ALLMin age: 15 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Adult trauma patient (estimated age \> 15 or weight \> 50 kg, if age unknown) 2. Patient taken to trauma center directly from scene 3. Commencement of blood transfusion (PRBC, plasma or LTOWB), in pre-hospital or in-hospital setting 4. Activation of site-specific Massive Hemorrhage Protocol or Massive Transfusion Protocol 5. Traumatic injury with at least one of the following: 1. Confirmed or suspected acute major bleeding 2. Assessment of Blood Consumption (ABC) Score ≥2 Exclusion Criteria: 1. 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. 2. Patients transferred from another hospital 3. 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) 4. 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) 5. Moribund patients expected to die within 1 hour 6. Patients who required an ED thoracotomy or received more than 5 consecutive minutes of cardiopulmonary resuscitation (prior to receiving randomized blood products) 7. Patients with known "do not resuscitate" orders prior to randomization 8. Patients who refuse the administration of blood products 9. Individuals with a research "opt out" bracelet. 10. Greater than 20% total body surface area (TBSA) burns 11. Suspected inhalation injury victims 12. Patients who are obviously pregnant on clinical examination or known to be pregnant as provided by the subject or legally authorized representative

Locations (13)

University of Alabama at Birmingham, UAB Hospital

Birmingham, Alabama, United States

RECRUITING

Los Angeles County + University of Southern California (LAC + USC) Medical Center

Outcomes

Primary Outcomes

6-hour Mortality

Participant vital status at 6-hours following randomization (randomization defined as product container is opened for administration to participant)

Time frame: First 6 hours after randomization

Secondary Outcomes

24-hour Mortality

Participant vital status at 24-hours following randomization

Time frame: First 24 hours after randomization

Hospital/30-day Mortality

Participant vital status at hospital discharge or 30-days post randomization (whichever the earlier)

Time frame: 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

Time frame: 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)

Time frame: 30-days post randomization

Length of Stay (Hospital and Intensive Care Unit)

Central Contacts

Shannon Stephens, EMTP, CCEMTP

CONTACT

205-934-5890 swstephens@uabmc.edu

Kiran Mansoor, MBBS

CONTACT

713-500-9643 Kiran.Mansoor@uth.tmc.edu

Data from ClinicalTrials.gov

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