UofL neurosurgeon leads clinical trial to test therapy for brain hemorrhage

UofL neurosurgeon leads clinical trial to test therapy for brain hemorrhage

Robert F. James, M.D., leading national phase II trial investigating low-dose heparin treatment following ruptured brain aneurysm
UofL neurosurgeon leads clinical trial to test therapy for brain hemorrhage

Robert F. James, M.D.

A Louisville patient is the first to be enrolled in a national clinical trial to test a new treatment for patients who have suffered a ruptured brain aneurysm. The trial, based at the University of Louisville under principal investigator Robert F. James, M.D., associate professor in the Department of Neurosurgery at UofL, will include eight other medical centers in the United States.

James, chief of neurosurgery at University of Louisville Hospital, part of KentuckyOne Health, and chief of the Division of Cerebrovascular and Endovascular Neurosurgery at UofL, is leading the ASTROH study, a phase II, randomized clinical trial to determine whether a continuous 14-day, low-dose intravenous infusion of heparin is safe and effective in patients with ruptured brain aneurysms.

“We believe this treatment may help prevent the long-term delayed neurological deficits (DNDs) and cognitive dysfunction that often afflict patients who survive the initial aneurysm rupture,” James said.

A brain aneurysm is a balloon-like bulge that forms when a segment of a blood vessel in the brain weakens and swells. If the aneurysm bursts, blood is leaked into the area between the brain and the thin tissues covering the brain known as the subarachnoid space. This condition is known as subarachnoid hemorrhage (SAH). Patients who survive the initial hemorrhage are at high risk for delayed secondary brain injury, resulting in problems with localized neurological functions such as speech, vision, hearing or individual areas of the body, and long-term cognitive and psychosocial deficits. These problems are referred to as SAH-induced delayed neurological deficits (DNDs).

The ASTROH study will examine whether the use of intravenous heparin for 14 days following the repair of the ruptured aneurysm will control neuro-inflammation and improve clinical outcomes. Patients who enter University of Louisville Hospital or one of the other participating medical centers having experienced a ruptured brain aneurysm may be evaluated for participation in the trial.

ASTROH, which stands for “Aneurysmal Subarachnoid Hemorrhage Trial RandOmizing Heparin,” will involve up to 88 patients at the nine medical centers over a period of two years. James is working with co-investigators at the University of Maryland, Yale University and Icahn School of Medicine at Mount Sinai. The trial is funded by the UofL Department of Neurosurgery through the UofL Research Foundation, Penumbra, Inc., MicroVention, Inc., and the Brain Aneurysm Foundation.