A minimally invasive procedure to remove blood clots in brain tissue after hemorrhagic stroke appears safe and may reduce long-term disability, according to late-breaking research presented Feb. 7 at the American Stroke Associations international conference in Honolulu.
Of the hundreds of thousands of Americans who have intracerebral hemorrhages each year, most are severely debilitated, noted Daniel Hanley, MD, the studys lead author and professor of neurology at Johns Hopkins School of Medicine in Baltimore.
ICH is the most common type of bleeding stroke. There has not been a specific evidence-based targeted treatment recommended for ICH nor any long-term randomized data on surgical treatment, according to the researchers.
In one-year results of the Phase II study, researchers found that patients treated with surgery and recombinant tPA had less disability, spent less time in the hospital and were less likely to be in a long-term care facility than were other ICH patients.
“There is now real hope that we have a treatment for the last form of stroke that doesnt have a treatment — brain hemorrhage,” Hanley, who also is director of the Brain Injury Outcomes Division at Johns Hopkins, said in a news release.
The overall study involved 96 patients at 26 hospitals who had a bleeding stroke. The Phase II arm of the trial focused on 25 patients who had the surgical procedure and 31 who were given standard post-stroke medical care, which is medical management only. The patients average age was 60, and 75% were men.
During the treatment, surgeons cut a hole the size of a dime in the patients skull. A catheter is passed into the brain tissue, pushing it through the longest part of the clot, which has formed from blood that pooled during the stroke. Next rtPA is applied to the clot via the catheter every eight hours for about three days. As the clot liquefies, it is removed through the catheter.
The studys patients had blood clots with an average volume of 46 milliliters, about the size of a golf ball, Hanley said. The procedure removed 57% of the clots on average, while clots naturally dissolved in only about 5% of the standard medical care group in the few days after stroke.
“The normal healing processes may be occurring more rapidly when you remove the blood,” Hanley said. “We believe were actually stopping brain injury and preserving brain tissue that would otherwise be lost.”
The researchers found less edema in the brains of the surgical patients four days after the procedure, compared with the usual care group.
In six-month results presented last year, the researchers noted that the surgical group had 11% better functional outcomes. The newest findings showed that a year after the stroke, the advantage in the surgery group had increased to 14%.
Likewise, year-long results among patients with mild disability also showed a 14% difference between the treatment groups. And compared with the usual care group, 14% fewer of the surgical patients were in long-term care a year later. “That 14% shift is occurring across the spectrum — from long-term care to moderate disability to mild disability,” Hanley said.
For patients who underwent the surgical procedure, median time spent in any level of hospital or rehabilitation care was 38 days shorter than for the usual care group. That difference could represent a cost savings per patient of more than $44,000, the researchers estimated.
Researchers noted that no hemorrhage was too large or too deep in the brain to be helped by the procedure. Patients who had surgery between 36 and 72 hours after their stroke fared as well as those treated sooner. Women and men, blacks and whites, and people older and younger than 65 appeared to benefit equally, although a larger study is needed to validate the findings. The researchers hope to conduct a 500-patient Phase III study at more than 75 sites.
Hanley said the training for surgeons is simple and the equipment is readily available. If the findings are confirmed, “then we have a practical treatment that can easily be done by all trained neurosurgeons. It could make a substantial difference in this disease.”
The study abstract is available at http://stroke.ahajournals.org/cgi/content/meeting_abstract/44/2_MeetingAbstracts/AWMP79.