The early use of cold-stored platelets as an early intervention for patients with injury and hemorrhagic shock is being studied by researchers at The University of Texas Health Science Center at Houston (UTHealth) as part of a national trial.
The UTHealth Center for Translational Injury Research is launching a Houston site for the Cold Stored Platelet Early Intervention (CriSP) trial at Memorial Hermann-Texas Medical Center.
Trauma is the leading cause of death for people younger than 45. The acute management of severely injured, bleeding patients has changed over the last decade, with the use of blood products (red blood cells, plasma, platelets, and whole blood) now given early and in equal ratios. But deaths from traumatic hemorrhage continue to occur in the first few hours after arrival at trauma centers, drawing attention to the need for additional early interventions.
Platelet transfusions are a vital component of initial resuscitation and essential to early control of bleeding. Currently platelets are not readily available in the prehospital or early resuscitation setting and typically not given until the patient has received multiple units of other blood products due to storage requirements and limited shelf life.
Cold-stored platelets, which can be refrigerated and stored similar to other blood products (red blood cells, plasma, and whole blood), could be beneficial if administered to a patient soon after arrival at a trauma center, instead of later as is the current standard treatment.
Bryan Cotton, MD, MPH, professor and the John B. Holmes Professor in the Clinical Sciences with McGovern Medical School at UTHealth, will be the principal investigator of the UTHealth trial site. Cotton is also director of the UTHealth Trauma and Surgical Care Fellowship Program at Red Duke Trauma Institute at Memorial Hermann-TMC.
“We have significantly reduced mortality from bleeding over the past 10 to 12 years, from greater than 50% for severely bleeding patients to the current 20-25%,” Cotton said. “Houston has led the way in identifying best practice for these patients and has performed many of the studies that have gotten us to where we are now. However, we haven’t been able to reduce further the mortality beyond 20-25%. This study will examine whether administering cold-stored platelets will reduce deaths from bleeding.”
The randomized trial will enroll 200 patients at seven level 1 trauma centers in the U.S. who are severely bleeding due to trauma and predicted to receive significant amounts of blood products.
Because a traumatic state is a requirement to enroll in the study, informed consent is not feasible. Researchers will contact family members and legally authorized representatives to obtain permission, and if neither can be located, the patient will be enrolled. For those enrolled without consent, consent will be sought from family members at the earliest opportunity.
In order to inform the community about the proposed study, Cotton and other members of the research team presented the study and answered questions at a series of meetings with groups in and around Houston. Researchers are also running a social media campaign to inform the public.
If you do not wish to participate in this proposed research study, please email firstname.lastname@example.org to obtain an “opt-out” bracelet that must be worn for the five-year duration of the study.
This research is supported by DoD contract W81XWH-16-D-0024 W81XWH19F0494. Any opinions, findings, and conclusions or recommendations expressed in this material are those of the author(s) and do not necessarily reflect the views of the Department of the Army, Department of Defense, or the U.S. Government. The trial is sponsored by the United States Department of Defense.
Co-investigators from the Department of Surgery in McGovern Medical School at UTHealth include Charles E. Wade, PhD, professor; and Erin Fox, PhD, associate professor.
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