Progesterone Offers No Significant Benefit in Traumatic Brain Injury Clinical Trial

Memphis, TN- The results of a national NIH-funded clinical trial, which was locally managed by Dr. Martin Croce of the University of Tennessee Health Science Center and Regional Medical Center, indicate that treatment of acute traumatic brain injury with the hormone progesterone provides no significant benefit to patients when compared with placebo.  Survival and favorable outcomes were not significantly different in the progesterone treated group than in the placebo treated group. Similar results from a separate industry funded clinical trial of progesterone in traumatic brain injury have been published.

The study, named ProTECT III, involved 49 trauma centers across the United States between July 2009 and November 2013. The study was originally planned to include 1,140 patients but was stopped after 882 patients because safety monitors determined that additional enrollment would be futile. The local study population included seventeen patients 18 years of age or older admitted to Regional Medical Center with moderate to severe brain injury who could be given study medication within 4 hours of injury. 

Additional information regarding the results of this study are available in the December 10, 2014 issue of the New England Journal of Medicine or by visiting the ProTECT website at: www.protectiii.com.

Civilian trauma study supports use of battlefield blood transfusion protocol

Memphis, TN - Working to save the lives of causalities suffering massive blood loss in the Afghanistan and Iraq Wars, United States military trauma surgeons developed a blood transfusion protocol that is employed in most military and civilian hospitals today.

Observational studies have suggested that this protocol, known as damage control resuscitation (DCR), improves patient outcomes after hemorrhagic shock. But to make sure, in 2012, researchers launched a large prospective clinical trial to gauge its effect on patient survival.

The results are in from the study involving 680 severely injured patients at 12 trauma centers in the United States and Canada - including Regional One Health and the Elvis Presley Memorial Trauma Center.  The study was led locally by Dr. Timothy Fabian, Professor and Chairman of the Department of Surgery at the University of Tennessee Health Science Center. Subjects included in this study were 15 years of age or older with profound injuries who received blood products within the first hour after admission and were predicted to require additional blood transfusions based on their condition.   Of the 680 patients enrolled in the study, 43 were enrolled locally.   Of the 43 local patients, 39 were male, 7 were female, 29 were African American, and 14 were White.   The ages were similar in both groups.

The findings appear in JAMA - the Journal of the American Medical Association - in an article titled "Transfusion of Plasma, Platelets, and Red Blood Cells in a 1:1:1 ratio vs a 1:1:2 Ratio and Mortality in Patients With Severe Trauma: The PROPPR Randomized Clinical Trial." This article was published on February 3, 2015.

In order to determine effectiveness and safety in this study, participating patients were assigned to one of two component therapies within 8 minutes of hospital arrival. One component therapy was administration of equal parts plasma, red blood cells and platelets (1:1:1) while the other was administration of one half the amount of plasma and platelets to red blood cells (1:1:2). The trial was built on the findings from an earlier trial showing that most trauma surgeons use one of these two component ratio therapies.

In a head-to-head comparison DCR, or 1:1:1, resuscitation reduced the risk of death due to blood loss during the first 24 hours. Thereafter, mortality rates in the two groups were about the same up to the trial's 30 day endpoint. Researchers also compared 23 complications and found no significant differences between the two blood transfusion protocols.

Dr. Fabian's local team included Dr. Martin Croce, Dr. Jordan Weinberg, Dr. Louis Magnotti, Dr. Thomas Schroeppel, Dr. George Maish, Dr. Gayle Minard, Dr. Stephanie Savage, Dr. Jay Mattingly, Dr. Christopher Sharp, Suzanne Wilson, RN and Stephanie Baggett, RN.    

Participating centers included UTHealth/Memorial Hermann-Texas Medical Center, the University of Alabama, the University of Arizona, the University of California, Los Angeles, the University of California, San Francisco, the University of Maryland School of Medicine, the University of Cincinnati, Oregon Health and Science University, the University of Tennessee Health Science Center, the University of Washington/Harborview Medical Center, Medical College of Wisconsin and Sunnybrook Health Science Center in Toronto.

PROPPR is a protocol of the Resuscitation Outcomes Consortium, which is funded by the NHLBI, the U.S. Department of Defense, the Defence Research and Development Canada, and the Canadian Institute of Health Research of Circulatory and Respiratory Health.