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February 2013
By Judith Hall
TRICS-II was a multi-centre randomized controlled pilot trial of two transfusion strategies in high risk patients undergoing cardiac surgery. Patients undergoing cardiac surgery were randomized to either a “restrictive” transfusion strategy (transfused when hemoglobin values were ≤75g/L) or a “liberal” transfusion strategy (hemoglobin ≤95g/L in the OR/ICU and <85g/L on the ward) and followed until discharge or 28 postoperative days.
The primary objective of this study was to determine the feasibility of enrolment into this trial and to determine whether study sites would be able to adhere to the two transfusion strategies. This study will provide the data to plan for a large international trial to definitively answer the question: “When should high risk patients undergoing cardiac surgery receive red blood cell transfusions?”, given the opposing risks of anemia and transfusion side-effects.
The Applied Health Research Centre (AHRC) acted as the trial coordination and data management centre and worked with the TRICS-II study sites to facilitate the ethics process and expedite the contracting process. AHRC staff trained all study investigators and coordinators on the protocol and data collection process via individualized web-conference training sessions. The data collection was performed using a web-based electronic case report form, and all entered data was reviewed and validated on an ongoing basis throughout the study.
Principal Investigators: Dr. David Mazer & Dr. Nadine Shehata, St Michael’s Hospital
Key challenge and solutions: This study was conducted at 9 Canadian centers, 1 international centre and 1 US centre. A key challenge was ensuring that all 11 sites had a common understanding of how to complete the web-based electronic case report form, and in particular the study definition of “adherence” was complex and often misunderstood in the early days of study enrolment. To overcome this challenge, each site was provided with individual web-based training, and bimonthly meetings were scheduled to facilitate ongoing communication and ensure a consistent message was communicated to study team members. AHRC developed and circulated monthly study newsletters and distributed “FAQ” documents to highlight common questions and concerns.
Results: Between January and November 2012 (11 months) 208 eligible patients were randomized, which was significantly quicker than the 18 month time period anticipated. The average monthly accrual rate was 2.6 patients per active site per month. While the credit for this achievement goes to the participating study sites, AHRC facilitated the speedy accrual period by working with sites to ensure that their REB and contracting processes were as smooth as possible and that the tools and documents needed to start recruitment were made available quickly and were intuitive and easy to use. Three study sites were started up within 3 months of the first REB submission, and 9 of the 11 sites were on board within 8 months. Thanks to the hard work of our dedicated team and participating study sites our patient recruitment goal was achieved 9 months ahead of schedule.
Judith Hall is the manager of the Clinical Trials Unit at the HUB.