Massachusetts General Hospital issued the following announcement on July 27.
That is the average time it takes for a person who has entered a hospital’s emergency department to reach an operating room.
For a patient suffering from an exsanguinating, noncompressible abdominal hemorrhage – a severe, life-threatening trauma – that is 36 minutes of continued blood loss.
What if there was a way to stop that person from bleeding out before they make it to the operating room, a way to put pressure on an otherwise noncompressible abdominal bleeding?
For 10 years, David King, MD, trauma and acute care surgeon in the MGH Trauma Center, and an engineering team, have been working to create ResQFoam, a self-expanding polyurethane trauma foam they hope will answer that question. King says the FDA has now approved the use of this potentially life-saving foam on patients in a clinical trial.
“In the history of medicine, the only way to stop internal bleeding has been through surgery,” King says. “With noncompressible abdominal hemorrhage following trauma, you can’t put pressure on the bleeding like you can with other body parts. This foam temporarily stops the bleeding, allowing critical time for the patient to make it to the operating room for surgery.”
ResQFoam is injected into the body, and it quickly expands to fill the abdominal cavity, applying pressure that may stabilize the patient. King says when the patient reaches an operating room, the foam is easily removed.
After a decade of research and preclinical work, 40 patients will be part of the clinical EFIC – exception from informed consent – trial of ResQFoam. “This study is for people who are so gravely injured they are likely to not survive, or will have a dismal outcome,” says King. “We’re not talking about the child who falls at soccer practice and comes in with a minor spleen injury. These are the most horrific injuries where the human body does not do well.”
For the next few months, King and his colleagues are reaching out to the community to share information about the clinical trial. “Part of this process is establishing a dialogue with the community and vetting what we think we have already figured out,” King says. “Especially at the MGH– where staff are so engaged, and the hospital means something to them – we want them to understand this is such a unique thing happening here.” Through town hall discussions, social media, advertisements on the MBTA and media outreach, Boston residents are invited to learn more, ask questions and be able to opt out of the study if they wish.
“It is incumbent on us as ethical researchers to make opting out easy,” says King. Anyone who wants to opt out of the clinical trial can request a special bracelet. More information can be found at resqfoam.com.
King says he hopes ResQFoam will save lives at the MGH, in hospitals throughout the country, on the battlefield and at any point of a trauma. “What we want to do is take something new, something that we think is better, and use it to save patients’ lives.”
Original source can be found here.