"Play the Winner" Clinical Trial of Endovascular Therapy for Refractory Vasospasm after Subarachnoid Hemorrhage (SAH)
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Dr. Stephan Mayer
Department of Neurology
Division of Critical Care Neurology
John Pile-Spellman, MD
Departments of Radiology and Neurosurgery
Robert A Solomon, MD
Department of Neurosurgery
The proposed study is a prospective, intent-to-treat, evaluator blinded, controlled, "play-the-winner" clinical trial to determine if patients with medically refractory symptomatic vasospasm after SAH, treated with endovascular therapy, will as a group, have a better neurological outcome than patients who are treated with standard medical therapy alone at three months based on the Glasgow Outcome Score.
Potential subjects include patients ages 18-90, who have suffered an aneurysmal SAH diagnosed by CT or lumbar puncture and confirmed by angiography, and have had the aneurysm successfully treated by surgical or endovascular means on or before day 6 after SAH. If a patient fails to respond to standard medical therapy, they will be randomly assigned into one of two treatment arms: 1) continued medical treatment alone, or 2) angioplasty plus continued medical treatment. Patients randomized to receive angioplasty will undergo an emergency angiogram. Angioplasty will follow if narrowed arteries are identified and the procedure can be safely performed. Patients will participate in a 40 minute in-person follow-up evaluation at three months after the date of their bleed to evaluate the long-term outcome of their condition.
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Affiliated with New York-Presbyterian Hospital || Last updated:
April 2, 2012