CLINICAL TRIAL / NCT05638581
Trauma Resuscitation With Low-Titer Group O Whole Blood or Products
- Interventional
- Active
- NCT05638581
Contact Information
Trauma Resuscitation With Low-Titer Group O Whole Blood or Products
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.
Gender
All
Age Group
15 Years and up
Accepting Healthy Volunteers
No
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
- Shock