OCT
03

Clinical Trial Participation and Placebo: The Unsung Heroes During Consent Discussions

From the perspective of a patient or a patient’s family during the time of a medical crisis the idea of consenting to an investigational trial can be very stressful. Most will focus on the risks of the investigational therapy and will find it difficult to realize the inherent benefits of participating in a clinical trial and the possible benefits of receiving a placebo. Historically the mortality rate of a patient suffering an intraventricular hemorrhage can be as high as 80% per the literature. In comparison, a review of the IVH thrombolysis safety (Safety) trial unblinded data shows that participation in a clinical trial reduced mortality to about 20% in both treatment groups. Although the treatment assignments remain blinded, this appears to be holding true for the current CLEAR III trial as well with 30-day mortality below 40% in both treatment groups. An assessment of A/B mortality is done by a blinded statistician at the time of each death to ensure that survival is occurring at the expected rate in both groups. This trend of survival in subjects enrolled in the trials is attributed to the stringent stability protocols required by the protocol which include optimal catheter placement, daily CT scans to monitor for bleeding, and strict blood pressure and intracranial pressure management.

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NOV
03

Updated CLEAR-III Bedside Worksheets

The Bedside Worksheets for collecting data in the CLEAR-III trial were recently updated to better match the EDC screens as well as correct a few errors. Please download (see below) this new version and discard any older versions. Here's a summary of the changes.

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MISTIE-3 Site Locations