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CLEAR IVH: Removal of blood from ventricles may benefit patients with IVH
The addition of recombinant tissue plasminogen activator to standard care may improve functional status.
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Thrombolytic therapy coupled with extraventricular drainage may improve functional outcomes, results from a study suggested.
Researchers for the CLEAR IVH trial presented phase-2b data on the 180-day functional outcomes of the final 36 patients of the overall trial, which included 52 patients with intracranial hemorrhage.
The study protocol called for the administration of up to three doses of 1 mg tissue plasminogen activator (tPA) to the study participants through an extraventricular drainage catheter. Patients were followed and outcomes were assessed using several measurement tools including the modified Rankin Scale, The Glasgow Outcome Score, Barthel Scores and SIS-16 Stroke Impact Score.
“Appropriate criticism of the CLEAR idea is that you are going to preserve life but not improve function and leave people in an impaired state,” Daniel F. Hanley, MD, a professor of neurology at The Johns Hopkins School of Medicine in Baltimore, said in his presentation. “I would submit to you that we are not seeing that; at 30 days, we had five individuals who were totally normal.”
The researchers reported 17% 30-day mortality among the 52 patients, and a 20% mortality rate among the final 36 patients of the cohort. The researchers also reported that 17 patients had modified Rankin Scores of between zero and three at six months following the procedure. The Barthel score in those patients was 100, and the average NIH Stroke Scale and Glasgow Outcomes Scores were both zero.
“These data give me substantial encouragement that we can change the outcome and not leave individuals functionally impaired but alive,” Hanley concluded. “We are proceeding to a phase-3 trial with a specific hypothesis that extraventricular drainage plus recombinant tPA treatment of intraventricular hemorrhage increases the percent of modified Rankin Score patients at the zero to three cut point vs. that percent in patients treated with extraventricular drainage alone.”
For more information:
- Hanley D. #142. Presented at American Stroke Association International Stroke Conference 2009; February 17-20, 2009; San Diego.
