DALLAS, March 21 – Combining a minimally invasive surgery with clot-busting drugs may be a safe way to remove clots from deep inside the brain, according to research reported in today's rapid access issue of Stroke: Journal of the American Heart Association.
Researchers of this international study – the largest of its kind so far – say their results are encouraging.
Intracerebral hematoma – a blood clot caused by bleeding from a ruptured vessel in the brain – is associated with high death rates and severe disability, says lead investigator Onno Teernstra, M.D., Ph.D., department of neurosurgery, University Hospital Maastricht in Maastricht, the Netherlands.
There is no clear answer on the best form of treatment. Hematomas may subside spontaneously, or they can be removed surgically, or dissolved with clot-busting drugs then drained. Open-brain surgery may further traumatize brain tissue. Minimally invasive surgery limits tissue damage and takes less time.
In a study called Stereotactic treatment of Intracerebral Hematoma by means of a Plasminogen Activator (SICHPA), Teernstra and colleagues attempted to improve survival and functional outcome. The stereotactic procedure uses imaging equipment to precisely guide a tiny catheter directly into the hematoma, then drain it. The clot buster urokinase was injected directly into the clot to liquefy it before it was drained.
From March 1996 to May 1999, the study enrolled 71 patients at 13 European centers who had bleeding deep in the upper part of the brain. Thirty-six patients (average age 67, 58 percent male) were randomized to have surgery and 35 patients (average age 69, 56 percent male) to standard drug treatment without surgery. All patients had hematoma volume of more than 10 ml.
Teernstra says results from 70 patients (36 surgical patients and 34 non-surgical patients) were included in the analysis. Researchers performed the urokinase and drainage procedure in six-hour intervals over 48 hours.
They found that patients who underwent this minimally invasive procedure averaged an 18 milliliter (mL) reduction in hematoma size seven days after stroke compared with a 7 mL reduction in hematoma size in patients who received standard medical treatment. "That is equal to a 34 percent relative reduction in hematoma size, which may improve prognosis," Teernstra says.
"Death in the intervention group decreased from the predicted 88 percent to 56 percent in the surgical group and 59 percent in the non-surgical group," he says. "But no statistically significant difference in mortality and morbidity was found at 180 days."
He says it was very difficult to recruit patients for this study so it was halted after three years of open enrollment. The premature end to the study resulted in numbers too small to demonstrate efficacy. The results are nonetheless "encouraging enough to warrant further study, but perhaps the next study should be restricted to patients with a consistent grave prognosis such as deep hematomas. They are easy to recruit because open craniotomy is not considered a viable alternative," he says.
Teernstra says the reduction in death rate in the non-surgical patients was not anticipated; however it might be a study effect because patients in both groups were closely monitored and thus all benefited from an increase in supportive care.
Co-authors are S.M.A.A. Evers, Ph.D.; J. Lodder, M.D. Ph.D.; P. Leffers, M.Sc.; C.L. Franke, M.D., Ph.D.; and G. Blaauw, M.D., Ph.D.
Materials provided by American Heart Association. Note: Content may be edited for style and length.
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