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
Qualifiers
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
Treatments tested in this trial
- LTOWB
- Components
Treatment groups
1,100 Participants
are divided into 2 treatment groupsSponsors and collaborators
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