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. 2016 Oct 12;2016(10):CD002042. doi: 10.1002/14651858.CD002042.pub4

Carson 2011.

Methods Randomised, unblinded, parallel, 2‐group, multicentre trial
Participants Participants aged 50 years or older, who were undergoing surgical repair of a hip fracture, with Hb concentrations below 10.0 g/dL within 3 days after surgery and who had clinical evidence of cardiovascular disease or cardiovascular risk factors
Sample size = 2016
Interventions
  • The liberal group received packed RBC when their haemoglobin level dropped below 10.0 g/dL.

  • The restrictive ('symptomatic strategy') group received transfusion if they developed symptoms of anaemia or if Hb fell below 8.0 g/dL.

Outcomes The primary outcome was inability to walk 10 feet (or across a room) without human assistance or death prior to closure of the window for 60‐day mortality. Other outcomes were 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, cognition (Gruber‐Baldini), mortality at 30 days, and long‐term mortality (Carson 2014).
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Data co‐ordinating centre staff prepared randomisation schedules for each site using randomly ordered block sizes of 2, 4, 6, or 8.
Allocation concealment (selection bias) Low risk The trial used an automated telephone randomisation system.
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk After random allocation, clinical site staff, clinicians, and participants were not blinded to treatment assignment.
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk The primary and secondary outcomes were assessed blinded to treatment assignment.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk There was nearly complete reporting data for primary outcomes and most secondary outcomes.
Selective reporting (reporting bias) Low risk There was complete reporting.
Other bias Low risk No other biases identified.