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. Author manuscript; available in PMC: 2014 Sep 23.
Published in final edited form as: Cochrane Database Syst Rev. 2012 Apr 18;4:CD002042. doi: 10.1002/14651858.CD002042.pub3
Methods Randomised, unblinded, parallel, 2-group multicentre trial
Participants Patients 50 years or older, who are undergoing surgical repair of a hip fracture, with Hb concentrations below 10.0 g/dL within 3 days after surgery and who have clinical evidence for cardiovascular disease or cardiovascular risk factors Sample size = 2016
Interventions
  • Liberal group - receive packed RBC when haemoglobin level dropped below 10.0 g/dL

  • Restrictive (’symptomatic strategy’) group - receive transfusion if develop symptoms of anaemia or if Hb falls below 8.0 g/dL

Outcomes Primary outcome is inability to walk 10 feet (or across a room) without human assistance or death prior to closure of the window for the 60-day, 30 and 60-day mortality. Other outcomes are Hb concentration, acute coronary syndrome (ACS), in-hospital myocardial infarction, unstable angina or death, disposition on discharge, survival, functional measures, fatigue/energy, readmission to hospital, pneumonia, wound infection, thromboembolism, stroke or transient ischaemic attack
Notes
Risk of bias
Bias Authors’ judgement Support for judgement
Random sequence generation (selection bias) Low risk Data Co-ordinating Center staff prepared randomisation schedules for each site using randomly ordered block sizes of 2, 4, 6 or 8
Allocation concealment (selection bias) Low risk Used an automated telephone randomisation system
Blinding (performance bias and detection bias)
All outcomes
Unclear risk After random allocation, clinical site staff, clinicians and patients were not blinded to treatment assignment. Primary and secondary outcomes were assessed blinded to treatment assignment
Incomplete outcome data (attrition bias)
All outcomes
Low risk Intention-to-treat analysis
Selective reporting (reporting bias) Low risk -
Other bias Low risk -