Back to resultsTrauma Resuscitation With Low-Titer Group O Whole Blood or Products (TROOP)
Primary Purpose
Wounds and Injuries, Shock, Hemorrhagic
Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
LTOWB
Components
Sponsored by
About this trial
This is an interventional treatment trial for Wounds and Injuries focused on measuring Massive Transfusion, Trauma, Shock, Hemorrhage, Plasma, Platelets, Red Blood Cells, Low-Titer Group O Whole Blood, Blood components
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Sites / Locations
- University of Alabama at Birmingham, UAB HospitalRecruiting
- Los Angeles County + University of Southern California (LAC + USC) Medical Center
- University Medical Center New Orleans LCMC Health
- University of Maryland Medical Center
- Washington University School of Medicine
- Atrium Health Wake Forest Baptist
- University of Cincinnati Medical CenterRecruiting
- Oregon Health and Sciences University Hospital
- Penn Presbyterian Medical Center
- University of Texas Health Science Center Houston
- University of Texas Health San Antonio and University Health System
- Harborview Medical CenterRecruiting
- Froedtert Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
LTOWB
Components
Arm Description
Participants randomized to receive (Low Titer O Whole Blood [LTOWB])
Participants randomized to receive the component blood products.
Outcomes
Primary Outcome Measures
6-hour Mortality
Participant vital status at 6-hours following randomization (randomization defined as product container is opened for administration to participant)
Secondary Outcome Measures
24-hour Mortality
Participant vital status at 24-hours following randomization
Hospital/30-day Mortality
Participant vital status at 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
Adjudicated Primary Cause of Death
Primary cause of death as reviewed and determined by the study investigators (consensus)
Length of Stay (Hospital and Intensive Care Unit)
Number of hours hospitalized (includes both hospital and intensive care unit time)
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.
Incidence of major surgical procedures
The proportion of participants undergoing major surgical procedures.
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.
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.)
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.
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.
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.
Full Information
NCT ID
NCT05638581
First Posted
November 8, 2022
Last Updated
August 11, 2023
Sponsor
University of Alabama at Birmingham
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), The University of Texas Health Science Center, Houston
1. Study Identification
Unique Protocol Identification Number
NCT05638581
Brief Title
Trauma Resuscitation With Low-Titer Group O Whole Blood or Products
Acronym
TROOP
Official Title
Trauma Resuscitation With Low-Titer Group O Whole Blood or Products
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 27, 2023 (Actual)
Primary Completion Date
December 31, 2026 (Anticipated)
Study Completion Date
June 30, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), The University of Texas Health Science Center, Houston
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wounds and Injuries, Shock, Hemorrhagic
Keywords
Massive Transfusion, Trauma, Shock, Hemorrhage, Plasma, Platelets, Red Blood Cells, Low-Titer Group O Whole Blood, Blood components
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
1100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
LTOWB
Arm Type
Active Comparator
Arm Description
Participants randomized to receive (Low Titer O Whole Blood [LTOWB])
Arm Title
Components
Arm Type
Active Comparator
Arm Description
Participants randomized to receive the component blood products.
Intervention Type
Biological
Intervention Name(s)
LTOWB
Intervention Description
Participants will receive Low Titer O Whole Blood administered intravenously or intraosseously.
Intervention Type
Biological
Intervention Name(s)
Components
Intervention Description
Participants will receive separated blood components (i.e., units of red cells, plasma, platelets, and cryoprecipitate) co-administered intravenously or intraosseously.
Primary Outcome Measure Information:
Title
6-hour Mortality
Description
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 Outcome Measure Information:
Title
24-hour Mortality
Description
Participant vital status at 24-hours following randomization
Time Frame
First 24 hours after randomization
Title
Hospital/30-day Mortality
Description
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)
Title
Incidence of Pre-specified Complications
Description
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)
Title
Adjudicated Primary Cause of Death
Description
Primary cause of death as reviewed and determined by the study investigators (consensus)
Time Frame
30-days post randomization
Title
Length of Stay (Hospital and Intensive Care Unit)
Description
Number of hours hospitalized (includes both hospital and intensive care unit time)
Time Frame
From randomization to hospital discharge or 30-days post randomization (whichever the earlier)
Title
Hospital-, Ventilator- and Intensive Care Unit-free days
Description
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.
Time Frame
30-days post randomization
Title
Incidence of major surgical procedures
Description
The proportion of participants undergoing major surgical procedures.
Time Frame
From randomization to hospital discharge or 30-days post randomization (whichever the earlier)
Title
Time to hemostasis in those undergoing procedures with a hemostatic component
Description
Time to hemostasis refers to the time that the subject achieved hemorrhage control (anatomic hemostasis and resuscitation complete) following emergency department arrival.
Time Frame
From randomization to hospital discharge or 30-days post randomization (whichever the earlier)
Title
Number and type of blood products used until hemostasis is achieved and from hemostasis to 24 hours after randomization
Description
The number of units and type of blood products (e.g. whole blood, packed red blood cells, platelets, plasma, etc.)
Time Frame
First 24 hours after randomization
Title
Discharge destination
Description
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.
Time Frame
At hospital discharge or 30-days post randomization (whichever the earlier)
Title
Functional status
Description
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.
Time Frame
From randomization to hospital discharge or 30-days post randomization (whichever the earlier)
Title
Patient's quality of life
Description
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.
Time Frame
From randomization to hospital discharge or 30-days post randomization (whichever the earlier)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shannon Stephens, EMTP, CCEMTP
Phone
205-934-5890
Email
swstephens@uabmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Shelly Sayre, MPH
Phone
713-500-9529
Email
Shelly.L.Sayre@uth.tmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Jansen, MBBS, PhD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham, UAB Hospital
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonah Celeski
Email
jonahceleski@uabmc.edu
First Name & Middle Initial & Last Name & Degree
Emily Turner
Email
elturner@uabmc.edu
First Name & Middle Initial & Last Name & Degree
Richard Betzold, MD
Facility Name
Los Angeles County + University of Southern California (LAC + USC) Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
University Medical Center New Orleans LCMC Health
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
University of Maryland Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Atrium Health Wake Forest Baptist
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
University of Cincinnati Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robbie Jones
Email
jones4rt@ucmail.uc.edu
First Name & Middle Initial & Last Name & Degree
Devin Wakefield
Email
wakefidm@ucmail.uc.edu
First Name & Middle Initial & Last Name & Degree
Michael Goodman, MD
Facility Name
Oregon Health and Sciences University Hospital
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Penn Presbyterian Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
University of Texas Health Science Center Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
University of Texas Health San Antonio and University Health System
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Harborview Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura Hennessy
Email
hennessy@uw.edu
First Name & Middle Initial & Last Name & Degree
Allison Larimore
Email
alari@uw.edu
First Name & Middle Initial & Last Name & Degree
Bryce Robinson, MD
Facility Name
Froedtert Hospital
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Not yet recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://trooptrial.org
Description
TROOP Consortium website
Learn more about this trial
Trauma Resuscitation With Low-Titer Group O Whole Blood or Products
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