Functional Outcomes in Cardiovascular Patients Undergoing Surgical Hip Fracture Repair (FOCUS)
Open BioLINCC Study See bottom of this webpage for request information
July 2003 - May 2009
December 14, 2010
January 13, 2016
Clinical Trial URLs
Primary Publication URLs
Commercial Use Data Restrictions No
Data Restrictions Based On Area Of Research No
Data available for request include analysis data related to the primary outcome paper.
The FOCUS trial tested the hypothesis that a higher threshold for blood transfusion would improve functional recovery and reduce morbidity and mortality, as compared with a more restrictive transfusion strategy.
Blood transfusions are frequently given to surgical patients and to the elderly. At the time of the FOCUS trial, the indications for postoperative transfusion had not been adequately evaluated and were controversial. One adequately powered trial involving adults in intensive care units showed a nonsignificant decrease in 30-day mortality with a restrictive transfusion strategy, as compared with a liberal strategy. However, the effect of a restrictive approach on functional recovery or risk of myocardial infarction in patients with cardiac disease had not been studied.
Patients 50 years of age or older who were undergoing primary surgical repair of a hip fracture and who had clinical evidence of or risk factors for cardiovascular disease were eligible if they had a hemoglobin level of less than 10 g/dL within 3 days after surgery. Originally, only patients with cardiovascular disease were eligible, however criteria was expanded to include patients with any of the following cardiovascular risk factors: a history of or treatment for hypertension, diabetes mellitus, or hypercholesterolemia; a cholesterol level of at least 200 mg/dL or a low-density lipoprotein cholesterol level of at least 130 m/dL; current tobacco use; or a creatinine level of more than 2.0 m/dL. A total of 2016 patients were enrolled with 1007 assigned to the liberal-strategy group and 1009 assigned to the restrictive-strategy group.
Participants were randomly assigned to the liberal-strategy group or the restrictive-strategy group. Clinical-site staff members, clinicians, and patients were aware of study-group assignments. Patients in the liberal-strategy group received one unit of packed red cells and additional blood as needed to maintain a hemoglobin level of at least 10 g/dL. An assessment of the hemoglobin level after transfusion was required, and an additional unit of blood was transfused if the patient’s hemoglobin level was below 10 g/dL. Patients in the restrictive-strategy group were permitted to receive transfusions if symptoms or signs of anemia developed or at the discretion of their physicians if the hemoglobin level fell below 8 g/dL. Blood was administered one unit at a time, and the presence of symptoms or signs was reassessed.
Hemoglobin levels were measured during hospitalization on days 1, 2, 4, and 7 after randomization. The assigned transfusion strategy was to be followed until discharge or up to 30 days, whichever came first. Transfusion was permitted at any time without measuring a hemoglobin level if the patient was bleeding and emergency transfusion was considered necessary by the treating physician. Blinded nurses telephoned patients or proxies at, or close to, 30 days and 60 days after randomization to ascertain outcomes after hospital discharge.
The primary outcome was death or an inability to walk 10 feet without human assistance at the 60-day follow-up. Secondary outcomes included a combined outcome of in-hospital myocardial infarction, unstable angina, or death for any reason.
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.
N Engl J Med. 2011 Dec 29; 365(26): 2453–2462.
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