Trauma Resuscitation With Low-Titer Group O Whole Blood or Products
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age15+
SponsorUniversity of Alabama at Birmingham
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
LTOWB
Biological/VaccineParticipants will receive Low Titer O Whole Blood administered intravenously or intraosseously.
Components
Biological/VaccineParticipants will receive separated blood components (i.e., units of red cells, plasma, platelets, and cryoprecipitate) co-administered intravenously or intraosseously.
Treatment groups
1,100 Participants
are divided into 2 treatment groupsGroup A: LTOWBActive comparator 1 intervention
Group B: ComponentsActive comparator 1 intervention
Trial outcomes
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)
Time frame
First 6 hours after randomizationSecondary outcomes
1
24-hour Mortality
Participant vital status at 24-hours following randomization
Time frame
First 24 hours after randomization2
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)3
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)4
Adjudicated Primary Cause of Death
Primary cause of death as reviewed and determined by the study investigators (consensus)
Time frame
30-days post randomizationSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Alabama at Birmingham
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
The University of Texas Health Science Center, Houston
Collaborator
Source ClinicalTrials.gov