JAN
22

200th Patient Enrolled in CLEAR-III

BIOS (Johns Hopkins' Brain Injury Outcomes clinical trial coordinating center) is thrilled to announce the CLEAR III consortium reached an important milestone today: enrollment in the CLEAR III trial has reached 200 patients! That means we are now 40% of the way to our goal of enrolling 500 patients by the end of 2014. At this rate, we are on target to complete enrollment six months or more ahead of schedule, something that will be a major accomplishment for this international study! What a great team of investigators and coordinators we have!!!

Congratulations to Dr. Agnieszka Ardelt (principal investigator), Cedric McKoy (coordinator), and the rest of the team at University of Chicago for enrolling patient #4200 today. As the treatment is blinded, we don't know whether this patient received tPA or the placebo, but after only 3 doses both the IIIrd and IVth ventricles are now open and his Modified Graeb score has dropped from 15 to 7, definitely an improved prognosis for this still critically-ill patient after experiencing a 30cc intracerebral hematoma that expanded into a large intraventricular hemorrhage.

We update the patient-by-patient enrollment information each week. Also, you can read the Quarterly Assessment of Performance (QAP) report, where we discuss the various metrics being followed in this trial and the tremendous performance of the approximately 70 sites participating in the CLEAR III intraventricular hemorrhage trial.

Another notable milestone: the results of the closely-related MISTIE II trial in intracerebral hematoma will be presented by Dr. Daniel Hanley at the International Stroke Conference in New Orleans on February 1st. Check the MISTIE study blog for details.

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DEC
21

Our newest member of BIOS


Audrey Wynnum Hall
was born on 20-December at 7:47 PM. Weighing 7 pounds and 15.4 ounces, Audrey is the newest member of the BIOS staff.  Her mom (Amanda Bistran-Hall, a site manager on the CLEAR and MISTIE teams) and Dad (Matt Hall) are very proud and doing great!Audrey Hall

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DEC
15

CLEAR-III Dec-2011 Webinar Features Early MISTIE Outcomes Analysis

Guyane at DSMB Oct11Attendees for this month's webinar received a special holiday treat: Gayane Yenokyan from the Hopkins Biostatistics Center presented a preliminary analysis of the MISTIE-II outcomes data.

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DEC
06

Welcome to the team, Corbin Bruce!

Jessica, the coordinator at Springfield had a baby in September. Please join us in welcoming Corbin Bruce to the CLEAR-III team. From the looks of it, I don't think he likes his queries!

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OCT
19

Report from the CLEAR-III DSMB Meeting (UPDATED)

[UPDATED 15-Nov] The Data Safety Monitoring Board (DSMB) for the CLEAR III clinical trial met today in both a closed session (to review unblinded data on the first 100 patients without the management team being present) and an open session where they asked questions of the project management and biostatistics teams from the BIOS Coordinating Center at Johns Hopkins. The official letter and a copy of the minutes have now been released and are attached below.

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MISTIE-3 Site Locations