Trauma Resuscitation with Group O Whole Blood or Products
Trauma is the leading cause of death in those under the age of 45 and the most common cause of preventable death after injury is bleeding. When someone is injured and they lose a lot of blood, they require an immediate blood transfusion.
When a person donates blood, it is typically separated into several components, such as red blood cells, plasma, platelets, and a few others. Injured patients who are bleeding require all of these parts, so it makes sense to use blood that has not been separated. This is called “Whole Blood”.
Whole blood is easier to give and may contain a better mixture of clotting factors. There are recent military and civilian studies suggesting that survival is better when patients receive whole blood, instead of previously separated blood products.
Research is normally only conducted with the express permission of the patient. However, it is often not possible to obtain patients’ consent to study treatments that are administered in life-threatening emergencies. The TROOP trial will therefore be conducted under federal regulations that allow for an exception from informed consent (EFIC) (see study links for more information on this).
The TROOP trial will be conducted in 13 leading trauma centers in the US and will include 1,100 patients. The trial will begin between early 2023 and last until 2027, and is funded by the National Heart, Lung and Blood Institute.
Study phase: III
Basic eligibility criteria:
Please contact the study coordinator for additional eligibility information.
This study is enrolling patients who meet the following criteria
- Age 15 years and older with weight equal to or greater than 110 lbs
- Patient taken to trauma center directly from scene
- Traumatic injury with major bleeding and activation of massive transfusion protocol
Primary disease category: Trauma & Emergency Medicine
This study is enrolling healthy volunteers.
Sponsor: National Heart, Lung and Blood Institute
Protocol number: TROOP
Projected enrollment dates: May 2024 to May 2027
Official study title: Trauma Resuscitation with Group O Whole Blood or Products (TROOP)
ClinicalTrials.gov page:
http://www.clinicaltrials.gov/show/NCT05638581