The purpose of this study is to help determine which blood transfusion combination will provide the best outcomes for the trauma patients receiving them. The two blood transfusion combinations which are a) 1 unit of red blood cells: 1 unit of plasma:1 unit of platelets compared to b) 2 units of red blood cells: 1 unit of plasma: 1 unit of platelets. Both combinations are in widespread use across the United States. This study will be conducted at 12 Level 1 trauma centers across the United States and Canada. Cotton and his team will be a part of this research team which will look at the resulting information to see if using one combination of blood products or the other can possibly increase the chances of survival and reduce complications.
The knowledge gained will likely impact the way in which patients who are severely bleeding are transfused, and lower the amount of otherwise preventable deaths resulting from hemorrhagic shock. The trauma surgeon on call in the emergency department will use information obtained when a patient arrives to the emergency department to predict if the patient will require a significant amount of blood products. The information includes their blood pressure, pulse, type of injury, and an ultrasound test to see if they are bleeding in the abdomen. For patients who are eligible for this study, the blood bank will be notified to randomize (a process like flipping a coin) the patient to receive one of two blood combination groups – one that gives more plasma and platelets and one that gives less. This is the investigational (or research) part of the study. All other treatments will be the same. If a patient is not in the study, the amount and type of blood products they receive will be decided by the trauma physicians, not by the randomization process for this study.
All blood is approved by the U.S. Food and Drug Administration (FDA) and the American Association of Blood Banks (AABB) and Health Canada. The blood used for this study will be just like the normal products patients get for transfusions. All blood is typed, and will be tested for infectious diseases. This is the standard practice for patients receiving a blood transfusion. Memorial Hermann-Texas Medical Center has policies and procedures established to safely transfuse blood products. As with any blood transfusion, there are risks involved, which include chance of transmission of an infectious disease, low blood pressure, allergic reaction, shortness of breath, fever and blood clotting problems. However, it is unknown at this time whether these risks are more severe or last longer (for example, lung injury) when one unit of red blood cells is administered for every unit of plasma and platelets compared with two units of red blood cells given with every unit of plasma and platelets.
The trauma physician will enroll incoming patients who are candidates for this study. This study will require the physicians to begin experimental emergency treatment without first obtaining informed consent of the patient or a legal representative and/or family member. All reasonable attempts will be made to contact a family member to discuss this study and obtain their permission for the patient to be in the study. The patient and/or family members can decide at any time to withdraw from the study if they choose. Patients who are enrolled in this study will be closely monitored for the first 24 hours they are in the hospital, frequently during the in- hospital stay and contacted after 30 days (if they have been discharged from the hospital) to follow up on how they are doing.
Patients who do not wish to be in this type of study will be given options for opting out. Anyone who does not wish to be involved in this study should contact Timothy Welch, study coordinator, at (713) 500-7298 and ask for an “opt out” bracelet or identification card (ID card) to be sent to them. The “Opt Out” bracelet is a colored, plastic bracelet with the word “PROPPR Ø” on it. The ID card will be about the size of a driver’s license or credit card with the word “PROPPR Ø” on it. If a person has this bracelet on when they arrive to the emergency department needing treatment, they will not be screened or enrolled in this study.
Cotton and members of the research team will present the project and field questions at a series of meetings with a variety of groups depicted as representatives of Houston, Harris County and surrounding cities and counties. A member of the Committee for the Protection of Human Subjects will also attend the meetings to assist in answering questions related to emergency consent issues and the study. Upon completion of the community consultation meetings, Cotton’s team will report back to CPHS, which will determine whether UTHealth will participate in this clinical trial.
To schedule a community consultation meeting or for more information, please contact Timothy Welch, study coordinator at (713) 500-7298.
Media Hotline: 713-500-3030