The Cleveland Clinic will lead a multicenter study examining a controversial surgical procedure for stroke patients with severe brain swelling -- removing a portion of the skull to relieve the buildup of pressure.
However, in a unique study approach, researchers will go beyond comparing the mortality rates of the surgical procedure and standard drug therapy. They plan to examine the quality of life for patients after treatment -- during which they will survey caregivers and patients. In particular, patients will be asked if the quality of their life justifies the potentially lifesaving procedure and would they want to go through it again, understanding the outcome.
"Just because medical professionals have the ability to do something, it doesn't mean they necessarily should do it. The critics argue that, even if the procedure is successful at saving lives, patients maintain a poor quality of life. Supporters have mostly anecdotal evidence that suggests otherwise," said Jeffrey I. Frank, M.D., director of the Cleveland Clinic's Neurointensive Care Program and co-principal investigator for the study. "The purpose of this study is to provide an objective, scientific examination of this procedure and to determine if it is indeed a humane option. A positive result will probably affect clinical practice for stroke patients."
The study -- Hemicraniectomy and Durotomy upon Deterioration for Massive Hemispheric Infarcts: A Multicenter Prospective Study (HEADDFIRST) -- begins on December 1. Investigators plan to enroll 138 patients over a two- to three-year period. The patients will be randomly selected to receive either standard medical treatment or the surgical decompression.
Large, high-risk strokes can cause severe brain swelling in some patients, almost always leading to death or debilitation. Standard medical therapy for this group of patients has a poor track record, said Dr. Frank. As a result, some physicians during the past few years have attempted surgical decompression as a last-ditch, lifesaving effort.
The philosophy behind surgical decompression is simple, Dr. Frank explained. As the brain swells, it runs out of room within the cranium, causing the brain to shift and sometimes twist the brain stem. That, in turn, blocks the flow of blood to the brain, leading to brain damage or death. By removing a portion of the skull (a hemicraniectomy), the pressure is relieved. Once the swelling goes down, the piece of skull is replaced.
"We know this is not a complete cure. Nearly all patients who survive incur some degree of disability, ranging from weakness of one side of the body to near-complete incapacitation," said Dr. Frank. "There are critics who say many of these people would be better off dead. Yet I believe we need obtain input from the survivors and their families to properly assess quality of life."
One recent non-randomized study of 53 patients in Germany reported that in-hospital mortality of patients undergoing the surgical procedure was 34.4 percent, compared to 76.2 percent of those receiving medical therapy. However, there have been questions about the methodology of that study, said Dr. Frank. The size and structure of the HEADFIRST trial should provide a much more reliable assessment of the effectiveness of the procedure, he said.
Approximately 20 major medical centers in the United States are participating in the study. Along with Dr. Frank, Derk Krieger, M.D., of the University of Texas-Houston, is co-principal investigator, and Cleveland Clinic neurosurgeon, Douglas Chyatte, M.D., is the primary neurosurgical investigator.
Contacts: Rob Whitehouse, 216/444-8927; Jim Armstrong, 216/444-9455
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