The University of New Mexico is participating in the ProTECT III trial – a National Institutes of Health sponsored research study that is testing if an intravenous infusion of progesterone can improve the outcome of someone who has suffered from a serious traumatic brain injury (TBI).
“At present, we don’t have an effective drug treatment to protect the brain from damage caused by a TBI. There is evidence that progesterone might help,” said Howard Yonas, MD, chair for the Department of Neurosurgery at UNM.
Because progesterone has been found to be most effective when given as soon as possible within four hours from the time of the traumatic brain injury, some patients may be enrolled in the study under special FDA rules known as “Exception from Informed Consent” (EFIC).
These special rules allow research studies in certain emergency situations to be conducted without consent. EFIC can only be used when: The person’s life is at risk, Existing treatments don’t work, The study might help the person, It is not possible to get permission from the person because of his or her medical condition or from the person’s guardian because there is a very short amount of time required to treat the medical problem. While previous studies have shown giving progesterone as early as possible after a TBI may protect the brain from damage, researchers stress there is no guarantee of benefit. Possible side effects include redness or inflammation at the IV site; blood clots, some serious or even fatal, and reduced resistance to infection, while receiving the study drug infusion. Participants will be monitored for all side effects and treated as needed. Enrollment at UNMH is underway and will continue until approximately December of 2014. Study participants will have suffered a serious brain injury, be at least 18 years of age, and meet eligibility criteria. Women who have a positive pregnancy test will not be enrolled in the trial. ProTECT participants will receive either a standard IV solution (placebo) or IV progesterone solution for up to 96 hours. Blood samples will also be taken to help predict how bad a patient’s head injury is and how well they will recover. Participants will receive all other standards of care for their injuries. The paramedics will notify the study staff of the patient’s injury and estimated arrival time and the study staff will meet the patient in the emergency department at UNM. If the patient is a candidate for ProTECT, attempts will be made to contact their legal guardian to obtain written consent. If after an hour of searching for a legal guardian, and one cannot be found the patient will be enroll without consent. Once the legal guardian is located, they will be asked to give their permission for the patient to continue in the study. For more information about ProTECT, visit the local ProTECT website at:http://www.protect.aemrc.arizona.edu/or the National website athttp://www.protectiii.com/Participants may withdraw from the study at any time with no disruption in care.
Contact: Cindy Foster, 272-3322