The researchers are currently seeking community input on the recommended project and a decision as to whether to proceed will be based on that input.
The idea is to see if cooling the body temperatures of people with an acute traumatic subdural hematoma can improve outcomes. This treatment is known as hypothermia and has been associated with encouraging results in preliminary studies and in other groups of patients, such as those with heart problems.
There are more than 40,000 traumatic subdural hematoma patients every year in the United States. An acute traumatic subdural hematoma is typically caused by a blow to the head and is characterized by a blood clot between the brain and the skull, which requires surgical intervention. The bleeding can compress brain tissue, resulting in injury and even death.
If the study goes forward, doctors would lower the body temperatures of people with this injury to 91.4 F while the blood clot is removed. Patients would be restored to a normal body temperature of 98.6 F after several days. The researchers would like to compare the outcomes of patients whose body temperatures were cooled prior to surgery with those whose body temperatures remained normal.
Dong Kim, M.D., the principal investigator for the proposed study, chair of The Vivian L. Smith Department of Neurosurgery at the UTHealth Medical School and director of the Mischer Neuroscience Institute at Memorial Hermann-TMC; and Georgene Hergenroeder, M.H.A., R.N., assistant professor and study director, and their research team are currently presenting information on the proposed study to community groups as well as fielding questions.
The study would be conducted at Memorial Hermann-TMC and doctors there would make the decision as to who would be a candidate according to stringent criteria.
This study may require doctors to begin treatment without first obtaining informed consent from the patient or a legal representative and/or family member. All reasonable attempts would be made to contact a family member to discuss this study and obtain permission for the patient to be in the study. Patients can later choose to withdraw from the data collection part of the study.
The study would be conducted in conjunction with doctors at the University of Miami and the University of Pittsburgh Medical Center and the goal would be to enroll 120 patients between the ages of 18 and 65 over four years. The project is titled HypOthermia for Patients requiring Evacuation of Subdural Hematoma: A Multicenter, Randomized Clinical Trial or the HOPES Trial for short.
The project is supported by the Vivian L. Smith Foundation for Neurological Research and ZOLL, a medical corporation.
Upon completion of the community consultation meetings, Kim’s team will report to the UTHealth’s Committee for the Protection of Human Subjects, which will determine whether the university will conduct this clinical trial.
For more information or to schedule a community consultation, email HopesTrial@uth.tmc.edu.
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