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

Wounds and Injuries Clinical Trial

— TROOP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05638581
• Other study ID #: 1UG3HL157401-01A1
• Secondary ID: 1UG3HL157401-01A
• Status: Recruiting
• Phase: Phase 3
• Start date: July 27, 2023
• Est. completion date: June 30, 2027

Study information

• Verified date: February 2024
• Source: University of Alabama at Birmingham
• Contact: Shannon Stephens, EMTP, CCEMTP
• Phone: 205-934-5890
• Email: swstephens[@]uabmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1100
• Est. completion date: June 30, 2027
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Shock, Hemorrhagic
• Wounds and Injuries

Intervention

Biological:
• LTOWB
Participants will receive Low Titer O Whole Blood administered intravenously or intraosseously.
• Components
Participants will receive separated blood components (i.e., units of red cells, plasma, platelets, and cryoprecipitate) co-administered intravenously or intraosseously.

Locations

Country	Name	City	State
United States	University of Maryland Medical Center	Baltimore	Maryland
United States	University of Alabama at Birmingham, UAB Hospital	Birmingham	Alabama
United States	University of Cincinnati Medical Center	Cincinnati	Ohio
United States	University of Texas Health Science Center Houston	Houston	Texas
United States	Los Angeles County + University of Southern California (LAC + USC) Medical Center	Los Angeles	California
United States	Froedtert Hospital	Milwaukee	Wisconsin
United States	University Medical Center New Orleans LCMC Health	New Orleans	Louisiana
United States	Penn Presbyterian Medical Center	Philadelphia	Pennsylvania
United States	Oregon Health and Sciences University Hospital	Portland	Oregon
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	University of Texas Health San Antonio and University Health System	San Antonio	Texas
United States	Harborview Medical Center	Seattle	Washington
United States	Atrium Health Wake Forest Baptist	Winston-Salem	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	National Heart, Lung, and Blood Institute (NHLBI), The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	24-hour Mortality	Participant vital status at 24-hours following randomization	First 24 hours after randomization
Secondary	Hospital/30-day Mortality	Participant vital status at hospital discharge or 30-days post randomization (whichever the earlier)	From randomization to hospital discharge or 30-days post randomization (whichever the earlier)
Secondary	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	From randomization to hospital discharge or 30-days post randomization (whichever the earlier)
Secondary	Adjudicated Primary Cause of Death	Primary cause of death as reviewed and determined by the study investigators (consensus)	30-days post randomization
Secondary	Length of Stay (Hospital and Intensive Care Unit)	Number of hours hospitalized (includes both hospital and intensive care unit time)	From randomization to hospital discharge or 30-days post randomization (whichever the earlier)
Secondary	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.	30-days post randomization
Secondary	Incidence of major surgical procedures	The proportion of participants undergoing major surgical procedures.	From randomization to hospital discharge or 30-days post randomization (whichever the earlier)
Secondary	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.	From randomization to hospital discharge or 30-days post randomization (whichever the earlier)
Secondary	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.)	First 24 hours after randomization
Secondary	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.	At hospital discharge or 30-days post randomization (whichever the earlier)
Secondary	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.	From randomization to hospital discharge or 30-days post randomization (whichever the earlier)
Secondary	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.	From randomization to hospital discharge or 30-days post randomization (whichever the earlier)

External Links

•   TROOP Consortium website