Prevention of Post-Traumatic Contractures with Ketotifen 2 (PERK 2)
Abstract
278 participants recruited by September 28, 2022. With 15 sites able to screen/recruit participants, we are maintaining an average of 12 participants enrolled per month. After receiving a no cost extension for the year 2022-2023, we are planning on maintaining recruitment efforts and covering operational logistics needed to reach the highest sample possible. Trial Steering Committee is working on a protocol amendment, proposing a sample size recalculation that would result in an attainable sample size that would still produce results originally outlined for the trial. Submission of amendment is scheduled for Q1 of year 6. Monthly Trial Management Group meetings continue to be held with site coordinators to maintain awareness of ongoing trial activities. Quarterly Trial Steering Committees were held, which informed TMG meetings on ways to improve and maintain enrollment efforts. Finally, three Data Monitoring Committee meetings (one closed and one open) were held, resulting in unbiased oversight of safety and efficacy points of the trial. DMC members recommended the trial to continue as planned.
Document Details
- Document Type
- Technical Report
- Publication Date
- Oct 01, 2022
- Accession Number
- AD1192608
Entities
People
- Kevin A Hildebrand
Organizations
- University of Alberta