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. 2021 Nov 26;2021(11):CD013307. doi: 10.1002/14651858.CD013307.pub3

Gruber‐Baldini 2013.

Study characteristics
Methods Design: RCT of liberal blood transfusion thresholds compared to restrictive transfusion practice for hip fracture patients
Date of study: April 2008‐February 2009
Power calculation: yes
Frequency of outcomes assessment: multiple times within 5 days after randomisation or up to hospital discharge (if hospital stay was shorter)
Inclusion criteria: aged 50 and older; undergoing surgical repair of hip fracture; Hb < 10 g/dL within 3 days after surgery; clinical evidence of cardiovascular disease or cardiovascular disease risk factors
Exclusion criteria: non‐English speaking; unable to walk unaided before fracture; declined blood transfusions; multiple traumas; pathological hip fracture; clinical acute myocardial infarction within 30 days pre‐randomisation; previous participants in the trial; symptoms associated with anaemia; actively bleeding at time of potential randomisation
Participants Number in study: 139
Country: USA and Canada
Setting: 13 hospitals
Age: mean age 82.4 (SD 7.4) in intervention group compared to 80.6 (SD 10.4) in control group
Sex: 81.8% of intervention group were female compared to 47% of control group
Co‐morbidity: numbers and percentages of common co‐morbidities reported in paper (stroke/TIA, chronic lung disease, cancer, diabetes, atrial fibrillation, Parkinson's disease, hearing problems, visual problems and alcohol abuse or withdrawal)
Dementia: 27.3% of intervention group had dementia compared to 36.1% of the control group
Frailty: not reported
Interventions Intervention (aka liberal treatment): one unit of packed red blood cells and as much blood as needed to maintain a Hb concentration >10 g/dL
Control (aka restrictive treatment): only transfused if symptoms of anaemia developed or at the study physicians discretion or if Hb < 8 g/dL
Outcomes Outcomes reported:
‐ Incident delirium, using CAM
‐ Delirium severity, using MDAS
‐ Length of admission
‐ Physical morbidity (post‐randomisation adverse events)
‐ Psychoactive medication use
Outcomes from study not reported: none
Frequency of outcomes assessment: multiple times within 5 days after randomisation or up to hospital discharge.
Notes Funding source: Research grant from National Heart Lung and Blood Institute
Declarations of interest: quote: "Dr Magaziner received support from Amgen, Eli Lilly, Glaxo SmithKline, Merck, Novartis and Sanofi Aventis to conduct research through his institution, provide academic consultation, or serve on an advisory board. Dr Roffey reports working as a consultant for Palladian Health. Dr Cardson reports receiving grant support to his institution from Amgen. Dr Marcantionio is a recipient of a Mid‐Career Investigator Award in Patient‐Oriented Research from the National Institute on Aging"
Delirium assessed at baseline but not excluded
>1/3 of the restrictive group received transfusion
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Automated central telephone randomisation system
Allocation concealment (selection bias) Low risk No evidence to suggest allocations revealed
Blinding of participants and personnel (performance bias)
All outcomes High risk Not blinded
Blinding of outcome assessment (detection bias)
All outcomes High risk Research staff unblinded to treatment status except at one site
Incomplete outcome data (attrition bias)
All outcomes Low risk 139 randomised, outcome assessment data available for 138
Selective reporting (reporting bias) Low risk Data reported for all participants included in the study
Other bias Low risk No evidence of other bias