New results from a multicenter study led by Johns
Hopkins show that patients who got an
experimental clot-busting treatment 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.
The findings, announced Feb. 19 at the International Stroke
Conference in San Diego, are likely to
build support for the use of tissue plasminogen activator,
or tPA, in patients with intracerebral
hemorrhage, a treatment-resistant form of stroke marked by
brain bleeding.
Last May, study leader Daniel Hanley, professor of
neurology at
the Johns Hopkins School of
Medicine, and his colleagues reported early findings among
52 intracerebral hemorrhage patients
treated with tPA given by catheter directly into the brain
to bathe and destroy blood clots with this
clot-busting agent. The researchers worked with patients at
38 study sites scattered throughout the
United States and in Canada, Germany and Finland.
The treatment, developed by Hanley's team, gives low
doses of tPA over several days after
strokes involving intracerebral hemorrhage, or ICH. This
drug normally isn't recommended for
conditions that involve bleeding, such as ICH, because it
can increase the risk of further hemorrhage;
however, since tPA is effective at breaking up clots in
other conditions, such as heart attacks and
other types of strokes, Hanley and his colleagues have been
studying its safety and efficacy for
treating ICH.
Early results from this 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. In the new study,
the researchers report 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.
The researchers 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.
Intracerebral hemorrhage 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 expect to start this clinical
trial imminently.
Other Johns Hopkins researchers who participated in
this study are Wendy Ziai, Ricardo
Carhuapoma, Neal Naff, Becky Sullivan, Timothy Morgan, Eric
Melnychuk, Susan Rice, Amber Stahl,
Shannon LeDroux, Amanda Bistran and Karen Lane.