UTHSC and the Elvis Presley Memorial Trauma Center (located in the Regional Medical Center at Memphis) have been selected to participate in a nationwide study sponsored by the National Heart, Lung and Blood Institute.th.
The University of Tennessee Health Science Center (UTHSC) and the Elvis Presley Memorial Trauma Center (located in the Regional Medical Center at Memphis) have been selected to participate in a nationwide study sponsored by the National Heart, Lung and Blood Institute, a subsidiary of the National Institutes of Health. Known as the PROPPR (Pragmatic, Randomized Optimal Platelet and Plasma Ratios) study, this research will examine two common methods for transfusing blood products in patients requiring massive transfusions following traumatic injury. The purpose of the study is to determine if one transfusion method leads to better patient outcomes than the other. The study will be headed locally by Timothy C. Fabian, MD, chairman of the Department of Surgery at UTHSC, and Martin Croce, MD, professor and UTHSC division chief of Trauma and Critical Care Surgery.
This study will involve three types of blood products given to patients who are hemorrhaging. These blood products are red blood cells, platelets and plasma. Two common ways that doctors choose to give these blood products following injury is to give either one unit of red blood cells for every unit of platelets and plasma, or to give two units of red blood cells for every unit of platelets and plasma. Currently, there is no scientific evidence that one method is better than the other. If, however, this study shows that one method is superior to the other, the knowledge gained will likely affect the way in which patients who are bleeding severely receive transfusions and may lower the amount of otherwise preventable deaths resulting from hemorrhagic shock.
Most research studies involve either a patient or a close family member who can speak for the patient making a choice of whether or not to participate in a study. However, in certain cases, the Food and Drug Administration may allow patients to be enrolled into select studies without prior consent. These special circumstances include the following:
The patient involved is in a life-threatening situation and participation in the research may offer benefit.
Consent cannot be obtained due to the patient’s medical condition and no family member is available to give permission for the patient to participate.
It is impossible to carry out the research if consent is required prior to study entry.
There is a defined “window of opportunity” for entering the patient in the study, and the study team has made every effort to contact a family member within the window for consenting.
It is anticipated that a patient qualifying for this study will be too ill to make his/her own decision on whether or not to participate. Additionally, most of the patients will not arrive with a family member who could make the decision for the patient regarding study participation. For this reason, this study will require that most patients be enrolled in the study first with permission to continue study procedures or a request to withdraw from the study being obtained as soon as possible afterwards.
More information regarding this study, including how to avoid enrollment into the study, may be obtained by contacting the study coordinators at (901) 448-4488 or by requesting information at the following e-mail address: email@example.com. To view the official Web site for the PROPPR study, go to http://cetir-tmc.org/research/proppr.