BALTIMORE — A Md. hospital is seeking community consent from trauma victims to study blood transfusions during fatal emergencies.
The University of Maryland Shock Trauma Center in Baltimore has found it difficult to conduct such studies because so many of its patients arrive in dire situations and clinging to life and cannot provide individual consent, according to the Baltimore Sun.
One of 12 in the country, the Shock Trauma Center hopes to bypass individual consent and agreement and have a blanket agreement that any patient who enters the hospital is subject to be part of the study.
The trial will run until 2015, when researchers hope that the years of data from the patients will help doctors know how to best transfuse blood products to patients who are bleeding out.
The Army is funding the study in hopes of figuring out the best transfusion ratio; patients would be split into random groups receiving different mixtures and ratios.
Patients who do not want to participate in the study must wear an armband signifying that they are not willing to be a part of the trial.
Dr. Thomas Scalea, head of the Shock Trauma Center, told the Baltimore Sun that the study would not subject patients to care different from what they normally would receive but would yield important results.
“I think it is vital that we do these studies,” he said. “I could be putting you at risk right now because I don’t know how the answer to what works best.”
The FDA approved such “community consent” rules in the 1990s, but medical ethicists are still unsure if it is fair not to have formal consent from individuals.
Proponents of the study say that the risks are low because the element of experimentation is minimal and that patients going into the trauma center would require transfusions anyway.
“What we need is the hard evidence on whether one ratio is better than the other,” said Col. Dallas Hack, the director of the Combat Casualty Care Research Program. “This is the final major step to give us that evidence.”
The hospital has done three studies in the past 10 years using “community consultation” and will reach out through radio and newspaper advertisements alerting residents of the study.