Starting as soon as next month, patients who arrive with a traumatic brain injury to emergency departments at Massachusetts General Hospital or Boston Medical Center could be enrolled in a medical study, possibly without their consent.
The trial, which has been approved by institutional review boards at both hospitals, will test whether administering progesterone in the hours immediately after an injury could limit brain damage. Doctors lack proven treatment options for the “secondary cascade” of injury that follows the initial trauma as cells continue to die, but early studies have shown that the hormone may slow that process.
Federal law requires researchers to get approval from the patient or a surrogate before administering an experimental drug. This is the first study approved at Boston hospitals using an exemption created in 1996 to study emergency treatments.
The Boston sites will join a national network of 40 hospitals studying the hormone in brain injury. The researchers will obtain consent if the patient can communicate or if family can be located within the hour following the injury. If that’s not possible, the medical staff will administer the drug and give the option of pulling out of the trial later.
Dr. Elizabeth Hohmann, physician director of the research review panels at Partners Health Care, Mass. General’s parent organization, said she was satisfied with the researchers’ outreach to patients and the effort to educate the broader community through surveys, focus groups, and public meetings.
“They accomplished everything that they said they would,” she said. “The study offers tremendous prospect for benefit to people who are severely injured, with little else to offer them, so the community felt very positive about it.”
The team must do additional technical training and meet with the national network leaders before enrolling patients, which likely will begin in August, said Dr. Eric Rosenthal, an investigator and associate director of the Mass. General neurosciences intensive care unit.
People who wish to opt out of the study, should they suffer a traumatic brain injury, may call (617) 726-7622.