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

Launched by UNIVERSITY OF ALABAMA AT BIRMINGHAM · Nov 28, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at two ways to give blood to critically injured patients who have experienced major bleeding. The researchers want to see if using whole blood from a specific type (called Low-Titer Group O Whole Blood) is just as effective, or maybe even better, than giving patients the separate parts of blood, like red blood cells and plasma. This study is important because it could help find the best way to treat patients who need a lot of blood quickly after a traumatic injury.

To be eligible for this trial, participants need to be adults (ages 15 and older) who have suffered serious injuries and are being treated at a trauma center right after their injury. They should start receiving blood transfusions either before or after arriving at the hospital and need to show signs of significant bleeding. If someone chooses to participate, they can expect to be part of a study that compares these two blood treatment methods, which could lead to improved care for future trauma patients. Remember, this trial does have specific rules about who can participate, such as not allowing patients who are very close to death, those with certain injuries, or those who refuse blood products.

Gender

ALL

Eligibility criteria

• 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