HOUSTON – (April 9, 2018) – Surgeons at The University of Texas Health Science Center at Houston (UTHealth) are seeking community input for a proposed study into the effectiveness of a potential treatment for trauma-related abdominal bleeding.
John Harvin, M.D., assistant professor of surgery with McGovern Medical School at UTHealth and an attending physician with the Memorial Hermann Red Duke Trauma Institute, is the principal investigator for the proposed two-year study.
Patients with severe internal abdominal bleeding have a high mortality rate. More than 40 percent of patients who lived long enough to receive emergency surgery still died at leading trauma centers, researchers report.
“Time-to-bleeding-control matters,” Harvin said. “The sooner we can stop bleeding or slow it, the more likely the patient is to live.”
Developed by Arsenal Medical and called ResQFoam, the experimental treatment works by increasing the pressure in the abdominal cavity using an expandable foam, thus decreasing the amount of blood loss. This product has been tested extensively in animals, but has not yet been tested in humans. ResQFoam has not been be approved by the Food and Drug Administration (FDA), but the clinical trial to assess it has received FDA approval.
The study is called “REVIVE: Reducing Exsanguination Via In-Vivo Expandable Foam” and there are additional testing sites.
Because of the severe nature of these injuries and the time-dependent nature of controlling bleeding, informed consent for participation is usually not feasible. In these instances, physicians may use ResQFoam in patients who qualify for the research study without their consent.
Informed consent would be obtained from patients or their next of kin as soon as possible. The research study would involve the collection of information regarding the types of injuries, the surgeries to stop bleeding and the post-operative outcomes until patient discharge.
“When patients arrive to our trauma center bleeding to death, they are usually unable to communicate with us or are in such pain or shock of what is going on that they are unable to provide truly informed consent,” he said.
“Additionally, some arrive without us knowing who they are and we don’t talk with them or their loved ones for many hours after injury,” he added.
In order to inform the community of the proposed study, Harvin and members of the research team are presenting the research study and answering questions at a series of meetings with groups in and around Houston.
A member of the Committee for the Protection of Human Subjects at UTHealth will also attend these meetings to assist in answering any questions related to informed consent issues in planned emergency research.
This research study is funded by Arsenal Medical and U.S. Department of Defense. Tentatively scheduled to begin later in 2018, researchers hope to enroll a total of 40 trauma patients from among the participating centers around the country. Approximately 10 to 15 patients are expected to be enrolled at UTHealth.
Individuals who do not wish to participate in this research study can email email@example.com to request for an “opt-out” bracelet that should be worn for the duration of the two-year study.
To schedule a community consultation meeting or for more information about this research study, visit the study webpage: https://www.uth.edu/ctrc/participants/efic/revive