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Transfusion Indication Threshold Reduction (TITRe2) randomized controlled trial in cardiac surgery: statistical
Katie Pike1, Rachel L Nash2, Gavin J Murphy3
1Clinical Trials and Evaluation Unit, School of Clinical Sciences, University of Bristol, Bristol, UK. katie.pike@bristol.ac.uk.
Trials
|April 17, 2015
Summary
The Transfusion Indication Threshold Reduction (TITRe2) trial will analyze red blood cell transfusion strategies in cardiac surgery patients. This statistical analysis plan ensures rigorous evaluation of restrictive versus liberal transfusion thresholds.
Area of Science:
- Cardiovascular Surgery
- Critical Care Medicine
- Hematology
Background:
- The Transfusion Indication Threshold Reduction (TITRe2) trial is a large randomized controlled trial investigating red blood cell transfusion strategies post-cardiac surgery.
- This update details the statistical analysis plan (SAP) for the TITRe2 trial, ensuring methodological rigor and adherence to CONSORT guidelines.
Purpose of the Study:
- To present the statistical analysis plan for the TITRe2 trial, outlining methods for analyzing primary and secondary outcomes.
- To detail the approach for handling non-adherence, withdrawals, missing data, and multiple testing in the trial analysis.
Main Methods:
- Randomized controlled trial involving 2000 patients across 17 UK centers.
- Comparison of a restrictive (Hb <7.5 g/dl) versus a liberal (Hb <9 g/dl) red blood cell transfusion strategy.
- Primary outcome: composite of serious infectious or ischemic events within 3 months post-randomization.
Main Results:
- The SAP details planned subgroup, sensitivity, and ancillary analyses.
- Methods for addressing potential issues in these analyses are described.
- The SAP ensures robust analysis of transfusion strategies' impact on patient outcomes.
Conclusions:
- The SAP provides a comprehensive framework for analyzing the TITRe2 trial data.
- This ensures transparent and reliable reporting of findings on red blood cell transfusion strategies.
- The analysis will inform clinical practice guidelines for transfusion in cardiac surgery patients.
