About TROOP
The purpose of the TROOP trial is to determine whether patients who are critically injured and need a large transfusion of blood should be given whole blood, or blood that has been separated into its individual components. Blood banks in the US usually separate blood into components like red cells, platelets, and plasma. This is helpful in non-emergency situations, because many patients only need certain components. Emergency rooms across the country use both methods (whole blood and component parts), however it has not been formally studied to see if one method of blood transfusion is more helpful to people in hemorrhagic shock than the other. If whole blood is proven to save more lives than blood components, or even just as good as components (because whole blood is easier to use), we hope more hospitals will start using whole blood for injured patients who are in hemorrhagic shock. This study is being conducted in 14 trauma centers around the US, and will enroll 1,100 people
It is not known whether the one transfusion method will be better than the other. For this reason, some study participants will receive whole blood and others will receive blood components. This will allow a careful comparison of the two types of transfusions. In the TROOP trial, participants are randomized, which means that the product they receive is determined randomly, like with the flip of a coin. After randomization, the whole blood or blood products will be transfused to the patient, while the doctors caring for the patient will perform surgery to repair the injury or injuries. Except for the blood transfusion(s), all of the treatments for the injuries will be determined by the physicians, and this study will not interfere with the patient’s care in any way.
Click here for link to TROOP Trial ClinicalTrials.gov entry
Blood Products in the Emergency Room
Whole blood and blood products are approved by the Food and Drug Administration (FDA) for use in patients with severe bleeding.
Whole Blood
Whole blood is blood which, following donation, has not been separated into its components. It contains red blood cells, white blood cells, and platelets suspended in a yellow liquid known as plasma.
Components of Blood
Whole blood can be separated into its main components, by a process called “spinning”. These components include red blood cells, plasma, and platelets. This is helpful in non-emergency settings, but in injured patients who are bleeding, all three components are required, and given at the same time – effectively reconstituting whole blood.
What are EFIC (Exception from Informed Consent) Trials?
EFIC (Exception from Informed Consent) Trials are clinical research activities which are carried out BEFORE obtaining consent from the patient or their family DUE TO a life-threatening medical emergency.
Important points about EFIC trials
- To conduct EFIC trials, researchers must prove that the study will potentially provide direct and real benefit to the patient. The treatment has to have shown promise in earlier studies.
- Although the study can begin without consent, once the patient is coherent or there is time to meet with a close relative, permission must be obtained to continue the research.
- If the patient is unable to provide consent for themselves, permission will be requested from the patient’s legal representative (Health care proxy).
- If the patient or the family chooses to not continue with the study their study participation will then stop at that point.
- The care of the patient is NOT affected by the decision to continue in the study or not.
- Federal rules for EFIC trials were developed in 1996 and are required to meet the highest ethical standards by various agencies’ in-depth inspection.
Click links below for more information on EFIC trials
How to conduct trauma research with patients who cannot say yes - News | UAB
Exception from Informed Consent Requirements for Emergency Research | FDA
The 14 participating TROOP trial locations are listed below:
- University of Alabama at Birmingham
- University Medical Center New Orleans Health LCMC Health (Tulane University School of Medicine)
- University of Texas Health Science Center Houston
- Oregon Health & Science University
- Washington University in St. Louis School of Medicine/ Barnes Jewish Hospital
- Wake Forest University Health Sciences (Atrium Health Wake Forest Baptist)
- University of Pennsylvania - Penn Presbyterian Medical Center
- University of Washington Harborview Medical Center
- Medical College of Wisconsin - Froedtert Trauma Hospital
- R Adams Cowley Shock Trauma Center
- University of Cincinnati Medical Center
- LAC/University of Southern California Medical Center (LAC+USC Medical Center)
- University of Texas Health San Antonio and University Health System
- University of Arizona College of Medicine Tucson