Principal Investigator: Thomas Scalea, MD
R Adams Cowley Shock Trauma Center
University of Maryland Medical Center
22 S. Greene St
Baltimore, MD 21201
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The Shock Trauma Center is participating in a research study involving severely injured patients that need a large amount of blood as part of their standard, live-saving treatment. The purpose of the PROPPR study is to learn which combination of blood products will improve their survival. The knowledge gained from this study will likely change the way blood is given to severely injured patients. The study may also help lower the amount of preventable deaths resulting from serious injury
Traumatic injuries, like those caused by car accidents or a shooting, are the leading cause of death in people under the age of 45. The main reason for death is losing too much blood. When a patient needs a lot of blood, they can be given blood products in different combinations. That is because when blood is donated, it is divided into its main active parts (or blood products). There are two blood products combinations that are in widespread use across the United States, but the medical community is unsure of which one produces the best results.
Patients who will need a very large amount of blood will be randomly assigned to one of two blood product combinations that are regularly used across the United States. In all other ways, patients enrolled in the study will be given the same high standard of life-saving care as given to patients who are not enrolled. Patients who are not enrolled may still receive one of the 2 blood product combinations if the doctor thinks they’ll need a large amount of blood as part of their standard, life-saving treatment
Usually, patients are told ahead of time about a research study so they can provide consent before participating. However, in the case of a severe injury in an emergency, it is often impossible for patients to give consent because they are unconscious or unable to communicate. The FDA regulations allow research studies to be carried out without first obtaining consent, but only under extremely strict conditions. This study meets these conditions. This is necessary because the patient will have a high risk of dying and treatment must begin immediately once in the Shock Trauma Center.
We will try to get consent from the patient or their legal representative or a family member before treatment begins or as soon as possible afterward. Patients who are enrolled without consent will be informed about the study as soon as they can communicate. They will be asked if they would like to continue in the study. Patients (and their legal representatives) always have the right to withdraw their participation from the study at any time. Individuals also have the right to request an ID bracelet or card so the Shock Trauma staff knows in advance if a patient does not want to participate in the study.