"Liberal or Restrictive Transfusion after Hip Fracture Surgery". The New England Journal of Medicine. 2011. 365(26):2453-2462. PubMed • Full text • PDF

Clinical Question

In elderly patients with known cardiovascular disease or risk factors undergoing surgery for hip fracture, does a liberal transfusion strategy improve recovery and reduce morbidity and mortality compared to a restrictive transfusion strategy?

Bottom Line

In elderly patients with cardiovascular risk factors undergoing surgery for hip fracture, a liberal transfusion strategy, as compared with a restrictive strategy, did not reduce rates of death or inability to walk independently at 60-day follow-up and did not significantly reduce in-hospital morbidity.

Major Points

Guidelines

At the time of publication, no updated guidelines reflecting the results of this trial were provided.

Design

- Multicenter, double-blind, parallel-group, randomized, placebo-controlled trial
- N=2,016 patients with recent hip fracture surgery and cardiovascular disease or risk factors
- Liberal transfusion strategy (target hemoglobin of ≥10 g/dL; n=1,007)
- Restrictive transfusion strategy (transfusions for anemia symptoms or hemoglobin <8 g/dL; n=1,009)
- Setting: 47 clinical sites in the United States and Canada
- Enrollment: 2004-2009
- Follow-up: 60 days
- Analysis: Intention-to-treat
- Primary outcome: Death or inability to walk 10 ft (or across a room) without human assistance at 60 days

Population

Inclusion Criteria
- Age ≥50 years
- Underwent primary surgical repair of a hip fracture
- Clinical evidence of or risk factors for cardiovascular disease
- Hemoglobin level <10 g/dL within 3 days after surgery

Exclusion Criteria
- Unable to walk without human assistance before hip fracture
- Declined blood transfusions
- Multiple trauma
- Pathologic hip fracture associated with cancer
- Acute myocardial infarction within 30 days before randomization
- Participation in the trial with contralateral hip fracture
- Active bleeding or symptoms associated with anemia at the time of potential randomization

Interventions

- Liberal-strategy group: 1 unit of packed red cells and additional blood transfused to maintain a hemoglobin level of ≥10 g/dL.
- Restrictive-strategy group: Transfusions permitted if symptoms of anemia developed or hemoglobin fell below 8 g/dL.

Outcomes

Primary Outcome
- Death or inability to walk without human assistance at 60-day follow-up: 35.2% in the liberal-strategy group and 34.7% in the restrictive-strategy group (odds ratio 1.01; 95% CI, 0.84 to 1.22; P=0.90)

Secondary Outcomes
- In-hospital acute myocardial infarction, unstable angina or death: 4.3% liberal-strategy vs. 5.2% restrictive-strategy (P not significant)
- Death on 60-day follow-up: 7.6% liberal-strategy vs. 6.6% restrictive-strategy (P not significant)
- Length of hospital stay, scores for physical activities of daily living, instrumental activities of daily living, and fatigue were similar between groups.
- Rates of residing at home at 30-day and 60-day follow-up were similar between groups.

Criticism
- Telephone ascertainment of functional outcomes may be subject to miscommunication and poorly informed proxy respondents.
- Walking ability and functional measure scores were not validated and were not useful for analysis for a substantial percentage of patients.

Funding

- Supported in part by grants from the National Heart, Lung, and Blood Institute.

Further Reading