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Release: Aug. 11, 2000

UI Hospitals and Clinics enrolls patients in clinical trial on hypothermia for aneurysm surgery

IOWA CITY, Iowa -- The University of Iowa Hospitals and Clinics is enrolling patients with ruptured aneurysms who may qualify to participate in a large, international, multicenter, prospective, randomized, partially blind clinical trial designed to evaluate whether hypothermia significantly improves long-term neurological outcome in patients undergoing open brain surgery for aneurysm clipping.

An aneurysm is an abnormally dilated portion of an artery within the brain. As the aneurysm expands it may rupture into an area surrounding the brain termed the subarachnoid space. Aneurysmal subarachnoidal hemorrhage occurs in more than 30,000 people per year in North America.

"This trial was designed after a pilot study demonstrated that hypothermia may be beneficial for patients operated on for ruptured aneurysms," said Mazen Maktabi, M.D., UI associate professor of anesthesia and principal investigator for the UI Hospitals and Clinics part of the trial. "Now we want to see if hypothermia really helps reduce neural injury following aneurysm clipping."

"Ruptured aneurysms are emergency cases for brain surgery," said the trial's lead neurosurgeon Vincent Traynelis, M.D., UI professor of surgery. "That's why we want community physicians who first see such patients to be aware of the ongoing trial to assure timely referral of appropriate patients."

Aneurysmal hemorrhage causes stroke of varied severity, but aneurysmal surgery places patients at risk for further injury. The trial is based on the hypothesis that mild reduction of body temperature to 33C during surgery can prevent additional injuries to the brain.

Nine hundred patients worldwide will be recruited before the trial's results can be processed and analyzed. Since the beginning of the trial in March 2000, the UI Hospitals and Clinics trial center has enrolled 12 patients, the greatest number among all U.S. trial centers to date.

 

University of Iowa Health Care describes the partnership between the UI College of Medicine and the UI Hospitals and Clinics and the patient care, medical education and research programs and services they provide.