and demographic characteristics. Results from daily CT scans from this study and the previous study showed that blood clots broke up over the first three days at similar rates for all three doses. Similarly, compared with a placebo, all doses substantially accelerated clot removal. But unlike the patients who received 3 milligram doses, none of the patients who received either 1 or 0.3 milligram doses experienced continued bleeding as a clinically significant side effect. Also, there were fewer deaths in each of the lower-dose groups, suggesting that the lower doses are safer.

Researchers also found that, although both lower-dose levels were equally effective at dissolving clots and reducing mortality rates, a sampling of the cerebral spinal fluid revealed that the 1 milligram dose stayed at therapeutic levels for longer periods of time than the 0.3 milligram dose. They also found that because the 1 milligram dose appears to clear the clot more rapidly from the third and fourth ventricles (sites of critical importance), the catheter can be removed sooner, greatly reducing risk of complications.

Hanley said the next step will be to conduct a randomized controlled phase-III trial where 500 patients will receive a 1 mg. dose of tPA.

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Contact: Eric Vohr
evohr1@jhmi.edu
410-955-8665
Johns Hopkins Medical Institutions
17-Feb-2006

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