A multicenter study showed that patients who got the clot-busting drug tissue plasminogen activator (tPA) for a particularly lethal form of stroke were not only dramatically more likely to survive but also continued to shed lingering disabilities six months later, according to findings presented this month at the American Stroke Association's (ASA) International Stroke Conference in San Diego.
In May 2008 study leader Daniel Hanley, MD, a professor of neurology at the Johns Hopkins School of Medicine in Baltimore, and colleagues reported early findings among 52 intracranial hemorrhage (ICH) patients treated with tPA given by catheter directly into patients' brains to bathe and destroy blood clots with tPA. The researchers worked with patients at 38 study sites scattered throughout the U.S., as well as Canada, Germany and Finland.
Since tPA is effective at breaking up clots in other conditions, such as MI and other types of strokes, Hanley and colleagues have been studying its safety and efficacy for treating ICH.
Early results from the study using information collected 30 days after tPA treatment showed that about 80 percent survived, compared to data from previous studies showing that about 80 percent of untreated ICH patients die. The researchers reported on the patients' progress six months after treatment using assessments for overall levels of disability as well as their skill in accomplishing specific tasks often affected by stroke, such as dressing, bathing or walking.
Investigators found that about 10 percent of patients had no lingering disability after six months. Another 40 percent had only mild to moderate disability and were independently caring for themselves at home by 180 days, but required assistance with everyday tasks such as lifting heavy objects. Even patients who were initially more severely disabled continued to improve months after treatment, with the majority scoring lower on disability assessments after six months compared to the same assessments taken at 30 days.
"We're painting a pretty good picture for quality of life after our treatment for ICH," Hanley said. "Survival doesn't have to mean just getting by--we're showing that it can mean truly living again." Hanley added that patients, families, physicians and ethicists worry deeply about the impact of stroke treatments that keep patients alive but leave them with a sharply curbed quality of life.
"Our new treatment appears to greatly increase patients' chances for survival and quality of life similar to what they experienced before they had their stroke," he said.
ICH causes blood to pool and clot inside the brain's interior cavities, building up pressure within the brain. The higher pressure, along with inflammation caused by chemicals in the trapped blood, can irreversibly damage the brain, usually leading to death or extreme disability.
Hanley and colleagues, with a clinical planning grant from the National Institute of Neurological Diseases and Stroke, will design a pivotal test to assess the value of tPA therapy on a much larger group of ICH patients. They said that they expect to start the clinical trial soon.