Doctors and researchers are hopeful that a protocol set to begin mid-1999 will aid them in determining whether a century old neurosurgical procedure should re-emerge as a modern treatment for stroke, and eventually trauma victims. Hemicraniectomy is a controversial, radical procedure in which a section of the skull of a stroke patient is temporarily removed to relieve pressure on the brain. Although documented cases of hemicraniectomy date back as far as the late 1800s, current debate explores whether the procedure restores sufficient quality of life, or leaves the patient alive but with a less than ideal prognosis. Answers to these questions may be found in the first such trial of its kind when Wayne State joins the national multi-center study called "Hemicraniectomy and Durotomy Upon Deterioration for Massive Hemispheric Infarcts: A Multicenter Prospective Study," or HEADFIRST.

Wayne State doctors William Coplin, Setti Rengachary, and colleagues will direct the School of Medicine’s role commencing July 1999 in this National Institutes of Health multi-center clinical trial which began early last year at the Cleveland Clinic in Ohio. Dr. Rengachary, a professor of neurosurgery, will serve as WSU’s chief surgical investigator in a team approach which includes neurologists, rehabilitation specialists, pharmacists and nutritionists from Wayne State and The Detroit Medical Center. He is recognized as a contemporary pioneer of the procedure, having authored a paper on three stroke patients in 1981, when hemicraniectomy re-emerged as a potentially viable treatment for stroke.

In head injuries and stroke, neurological damage generally is caused by swelling of the brain within the confined space of the skull. With increased swelling, the brain can no longer be contained in the cranium and thus shifts, with the brain stem possibly becoming twisted. Blood flow to the brain is impeded resulting in brain damage or death. In trauma cases, further complications can result from a badly contused temporal lobe tip or frontal lobe. The traditional approach in trauma situations has been to remove the lobes, with certain brain damage resulting. In a less invasive approach, a number of clinical trials currently underway in Wayne State’s neuroscience departments to test the efficacy of new drugs are showing promise for neurodegenerative disorders such as stroke, as well as cerebrovascular disease and Alzheimer’s disease.

Intervention by hemicraniectomy involves removal of a side portion of the skull to relieve pressure on the brain. The scalp and the dura, a tough inner membrane under the scalp, are then sewn together, which allows room for the brain to continue swelling underneath. After approximately three months, the brain recedes into the cranium and the skull is then replaced. During the healing, patients wear helmets for protection, and often carry the portion of the skull that has been removed in their abdomens to allow for the bone marrow to remain alive. The skulls can also be kept frozen throughout the healing process.

Having seen hemicraniectomy performed as a last-resort maneuver for trauma victims during residency, Dr. Coplin, an assistant professor in the departments of neurology and neurosurgery at the School of Medicine and medical director of the Neurotrauma Intensive Care Unit at Detroit Receiving Hospital, wondered whether by leaving the brain in place and giving it room to swell, certain neurons would perhaps declare themselves. "I’m not sure anyone can look at the temporal lobe and say with certainty that this neuron is bad, this neuron is OK, this neuron might make it," says Dr. Coplin. In many trauma cases he observed, traditional measures for controlling intracranial pressure - diuresis, sedation, paralysis, chilling - had failed. "I began to wonder, did we really have to wait until patients deteriorated or until all other medical therapies like dehydration, sedation or pharmacologic coma had failed before undertaking this?" he said. What would happen if such a procedure was employed before the patients deteriorated. Would doctors have a better chance of preserving the brain? Would patients have a better chance at life?

Similar issues were confronted in cases of stroke, and similar questions were again raised for Dr. Coplin. "We know that by doing nothing for hemispheric stroke, the mortality is 80-plus percent, so what happens if we let the brain swell?" he asked. "Using hemicraniectomy where traditional measures of controlling intracranial pressure have failed, I believe we can let certain neurons declare themselves as salvageable in some instances."

Intervention is critical in the earliest stages, given that clinical deterioration occurs within 96 hours: sleepiness begins, followed by coma and death by herniation, a process by which the brain is literally squeezed out of the skull. A study as recent as 1998 at the University of Heidelberg, Germany, concluded that the outcome of patients treated with early craniectomy in severe ischemic hemispheric infarction was "surprisingly good," based on a 73 percent survival rate in 63 patients; "early hemicraniectomy led to a significant reduction in the length of time critical care therapy was needed," reported the researchers in the September 1998 issue of Stroke.

A study of 43 patients a year earlier at Heidelberg indicated a mean survival rate of 72.1 percent and, notably, no surviving patients remained in a vegetative state. Doctors know that hemicraniectomy does not offer a complete cure, because nearly all patients who survive are left with some degree of disability. But they do know that by using the procedure, the mortality rate may effectively be reduced to less than 35 percent. Inherent in the procedure, however, is the critical question: what type of lifestyle, if any, remains for those whose lives have been restored?

As Dr. Coplin puts it, "We go from asking ‘are we going to save their lives’ because we know there is greater certainty of that, to asking ‘can we give them a functional outcome?’" Where previous studies of hemicraniectomy have compared mortality rates of the surgical procedure and standard drug therapy, the HEADFIRST study will enable doctors to obtain input from the survivors and their families to help them determine whether the degree of disability the patient is left with is acceptable to the patient, as well as the patient’s caregivers. In examining the quality of life for patients after undergoing the treatment, doctors will specifically ask if the patient’s quality of life justifies the procedure and would they want to repeat their experience, understanding the outcome. Critics will argue that patients are left with a poor quality of life, yet evidence to suggest otherwise has collectively been anecdotal from studies done primarily outside of the United States.

As director of the Neurotrauma Intensive Care Unit at DRH, Dr. Coplin is optimistic about craniectomy outcomes. Comparing 12 craniectomy patients with 17 traditional craniotomy patients, the craniectomy group demonstrated decreased mortality and functional outcomes similar to the craniotomy patients. Among the 17 individuals who underwent craniotomy, seven expired, eight went to inpatient rehabilitation, one went to a skilled nursing facility and one was discharged to inpatient psychiatry. Of those 12 individuals who underwent craniectomy, three expired, five went to rehabilitation, two went home and two went to a long-term skilled facility.

With 138 patients at 20 major U.S. medical centers participating in HEADFIRST, it is anticipated that the trial will provide a more reliable assessment of the effectiveness of hemicraniectomy. "This study will be as standardized as a medical protocol can be," said Dr. Coplin, "and it will finally provide the opportunity to track outcome."