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Randomized Controlled Trial
. 2011 Dec 29;365(26):2453-62.
doi: 10.1056/NEJMoa1012452. Epub 2011 Dec 14.

Liberal or restrictive transfusion in high-risk patients after hip surgery

Collaborators, Affiliations
Randomized Controlled Trial

Liberal or restrictive transfusion in high-risk patients after hip surgery

Jeffrey L Carson et al. N Engl J Med. .

Abstract

Background: The hemoglobin threshold at which postoperative red-cell transfusion is warranted is controversial. We conducted a randomized trial to determine whether a higher threshold for blood transfusion would improve recovery in patients who had undergone surgery for hip fracture.

Methods: We enrolled 2016 patients who were 50 years of age or older, who had either a history of or risk factors for cardiovascular disease, and whose hemoglobin level was below 10 g per deciliter after hip-fracture surgery. We randomly assigned patients to a liberal transfusion strategy (a hemoglobin threshold of 10 g per deciliter) or a restrictive transfusion strategy (symptoms of anemia or at physician discretion for a hemoglobin level of <8 g per deciliter). The primary outcome was death or an inability to walk across a room without human assistance on 60-day follow-up.

Results: A median of 2 units of red cells were transfused in the liberal-strategy group and none in the restrictive-strategy group. The rates of the primary outcome were 35.2% in the liberal-strategy group and 34.7% in the restrictive-strategy group (odds ratio in the liberal-strategy group, 1.01; 95% confidence interval [CI], 0.84 to 1.22), for an absolute risk difference of 0.5 percentage points (95% CI, -3.7 to 4.7). The rates of in-hospital acute coronary syndrome or death were 4.3% and 5.2%, respectively (absolute risk difference, -0.9%; 99% CI, -3.3 to 1.6), and rates of death on 60-day follow-up were 7.6% and 6.6%, respectively (absolute risk difference, 1.0%; 99% CI, -1.9 to 4.0). The rates of other complications were similar in the two groups.

Conclusions: A liberal transfusion strategy, as compared with a restrictive strategy, did not reduce rates of death or inability to walk independently on 60-day follow-up or reduce in-hospital morbidity in elderly patients at high cardiovascular risk. (Funded by the National Heart, Lung, and Blood Institute; FOCUS ClinicalTrials.gov number, NCT00071032.).

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Conflict of interest statement

No other potential conflict of interest relevant to this article was reported.

Figures

Figure 1
Figure 1. Lowest Daily Hemoglobin Levels
Shown are the lowest daily hemoglobin levels among patients in the liberal-strategy group versus those in the restrictive-strategy group. Data for the two groups are pooled on the day of randomization and are presented for days 1, 2, 4, and 7, when hemoglobin levels were required to be measured while patients remained in the hospital. The center line within each box represents the median, and the extremes the interquartile range.

Comment in

References

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