Adherence in a randomised controlled trial comparing ...
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Adherence in a randomised controlled trial comparing ...
Dec 13, 2011 - (TITRe2). Katie Pike*, Rachel Brierley, Chris A Rogers, Gavin J Murphy, Barney C Reeves. From Clinical Trials Methodology Conference 2011.
Pike et al. Trials 2011, 12(Suppl 1):A131 http://www.trialsjournal.com/content/12/S1/A131
TRIALS
ORAL PRESENTATION
Open Access
Adherence in a randomised controlled trial comparing liberal and restrictive red blood cell (RBC) transfusion protocols after cardiac surgery (TITRe2) Katie Pike*, Rachel Brierley, Chris A Rogers, Gavin J Murphy, Barney C Reeves From Clinical Trials Methodology Conference 2011 Bristol, UK. 4-5 October 2011 Objectives The TITRe2 trial is comparing two haemoglobin (Hb) thresholds for RBC transfusion after cardiac surgery, Hb24 hours after first breaching, but none has been randomised without or before breaching the 9.0g/dl threshold. 32% of participants have had ≥1 instance of non-adherence to the transfusion protocol; in 6%, non-adherence was judged severe (extra – transfused and patient did not breach at any point post-randomisation; withheld – not transfused and patient had no post-randomisation transfusions). Site-specific rates of non-adherence are being fedback to try to improve adherence. Rates of transfusion in the liberal and restrictive groups are confidential to the Data Monitoring and Ethics Committee (DMEC). Conclusions We believe that this is the first attempt to measure withheld transfusions in trials of this kind. Data collection to do this is burdensome but satisfactory. The current rates of transfusion in the liberal and restrictive groups are, so far, judged by the DMEC to be consistent with the sample size justification.
Bristol Heart Institute, University of Bristol, Bristol, BS2 8HW, UK
Pike et al. Trials 2011, 12(Suppl 1):A131 http://www.trialsjournal.com/content/12/S1/A131
Page 2 of 2
Published: 13 December 2011
doi:10.1186/1745-6215-12-S1-A131 Cite this article as: Pike et al.: Adherence in a randomised controlled trial comparing liberal and restrictive red blood cell (RBC) transfusion protocols after cardiac surgery (TITRe2). Trials 2011 12(Suppl 1):A131.
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