Liberal Transfusion No Help in Hip Surgery

Original Article

By Charles Bankhead, Staff Writer, MedPage Today Published: December 14, 2011 Reviewed by Robert Jasmer, MD; Associate Clinical Professor of Medicine, University of California, San Francisco and Dorothy Caputo, MA, RN, BC-ADM, CDE, Nurse Planner

Action Points   Hip-fracture patients with an increased cardiovascular risk gained no survival or functional benefits from liberal use of blood transfusion. Note that rates of inhospital coronary events or death were similar between groups, as was 60-day mortality. Hip-fracture patients with an increased cardiovascular risk gained no survival or functional benefits from liberal use of blood transfusions, results of a large randomized trial showed. The proportion of patients who died or could not walk unassisted at 60 days was about 35%, regardless of whether they received transfusions. Moreover, rates of inhospital coronary events or death were similar between groups, as was 60-day mortality, as reported online in the New England Journal of Medicine. "Our findings suggest that it is reasonable to withhold transfusion in patients who have undergone surgery in the absence of symptoms of anemia or a decline in the hemoglobin level below 8 g per deciliter, even in elderly patients with underlying cardiovascular disease or risk factors," Jeffrey L. Carson, MD, of the University of Medicine and Dentistry of New Jersey in New Brunswick, and co-authors wrote in conclusion. Hospitalized patients in the U.S. receive more than 15 million units of red cells each year. Surgical patients and older patients frequently receive transfusions despite limited evidence to support postoperative administration, according to background information. In particular, no studies have examined the effect of a restrictive transfusion policy on functional recovery and risk of myocardial infarction (MI) in patients with cardiac disease, the authors wrote. To address that issue, investigators at 47 sites in the U.S. and Canada enrolled patients in the Transfusion Trigger Trial for Functional Outcomes in Cardiovascular Patients Undergoing Surgical Hip Fracture Repair (FOCUS). The FOCUS trial involved patients at least 50 years of age with cardiovascular disease or risk factors and who underwent primary surgical repair of a hip fracture. Eligible patients had a hemoglobin level <10 g/dL within three days after surgery. Patients were randomized to a liberal or restrictive strategy of transfusion. The liberal protocol stipulated that every patient would receive one unit of packed red cells, followed by additional transfusions as necessary to maintain a hemoglobin level ≥10 g/dL. Patients assigned to the restrictive strategy could receive transfusions if they developed signs or symptoms of anemia or at the discretion of the treating physician if the hemoglobin level declined to <8 g/dL. Signs or symptoms that could trigger transfusion were chest pain of presumed cardiac origin, congestive heart failure, and unexplained tachycardia or hypotension unresponsive to fluids. All patients had hemoglobin measurements on days one, two, four, and seven and additional measurements if clinically indicated. The randomized transfusion strategy continued until discharge or for as long as 30 days, whichever came first. The primary endpoint was the composite of death or inability to walk unassisted across a room at 60 days. The study involved 2,016 patients who had a mean age of 81, three-fourths were women, and 94% were white. About 40% of the patients had coronary artery disease, 17% had CHF, 23% had cerebrovascular disease, and 11% had peripheral vascular disease. More than 80% of the patients had hypertension, 35% had hypercholesterolemia, and 25% had diabetes. About 51% of the patients had intertrochanteric hip fractures, and 42% had fractures of the femoral neck. Patients randomized to the liberal transfusion strategy received a median of two units of red cells. Patients assigned to the restrictive strategy received 65% fewer units of blood, and half of the patients in that group received no transfusions. The primary analysis showed 35% of patients in the liberal-transfusion group met the primary endpoint compared with 34.7% of patients randomized to the restrictive transfusion strategy. Additionally, 4.3% of the liberal-transfusion arm had an acute coronary syndrome or died in hospital compared with 5.2% of patients in the restrictive-transfusion arm. The 60-day mortality was 7.6% with the liberal transfusion strategy and 6.6% with the restrictive strategy. Complication rates also were similar between the two groups. The interpretation that the "transfusion strategy makes no difference in functional outcome in patients without symptoms of anemia is likely to be correct," the authors of an accompanying editorial wrote. Nevertheless, the effect of a transfusion strategy on adverse events remains unresolved, although rates were low in the trial. "The decision to transfuse should be guided by an assessment of individual patients on the basis of a combination of signs, symptoms, and laboratory measures, and not by a single hemoglobin level," wrote Paul J. Barr, PhD, of Queen's University Belfast in Ireland, and Karen E. M. Bailie, MD, PhD, of the West of Scotland Blood Transfusion Center in Glasgow in an editorial published with the study. "Despite these caveats, the FOCUS trial provides new evidence to support the view that a more restrictive transfusion threshold in the absence of symptoms of anemia may be reasonable, including in elderly patients at risk for cardiovascular events," Barr and Bailie added. "Such a policy would reduce exposure to allogeneic blood transfusion with its attendant risks and costs." The study was supported by the National Heart, Lung and Blood Institute. Carson disclosed a relationship with Amgen. Co-authors disclosed relationships with Abbott, Alere, Beckman Coulter, Ortho Clinical Diagnostics, Instrumentation Laboratories, Siemens, Roche Diagnostics, BioRad, Response Biomedical, Radiometer, BRAHMS, Amgen, Novartis, GlaxoSmithKline, Eli Lilly, and Merck. Barr and Bailie had no relevant disclosures.

Primary source: New England Journal of Medicine Source reference: Carson JL, et al "Liberal or restrictive transfusion in high-risk patients after hip surgery" N Engl J Med 2011; DOI:10.1056/NEJMoa1012452. Additional source: New England Journal of Medicine Source reference: Barr PJ, Bailie KEM "Transfusion thresholds in FOCUS" N Engl J Med 2011; DOI:10.1056/NEJMe111087. Another article siting this study can be found here: http://www.medscape.com/viewarticle/756092?sssdmh=dm1.746001&src=nldne