N Engl J Med. 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.
Carson JL1,
Terrin ML,
Noveck H,
Sanders DW,
Chaitman BR,
Rhoads GG,
Nemo G,
Dragert K,
Beaupre L,
Hildebrand K,
Macaulay W,
Lewis C,
Cook DR,
Dobbin G,
Zakriya KJ,
Apple FS,
Horney RA,
Magaziner J;
FOCUS Investigators.
Carson JL, Terrin ML, Beaupre L, Chaitman BR, Dobbin G, Fleisher LA, Greenburg AG, Hébert PC, Heck DA, Hildebrand KA, Kaplan H, Lewis C, Magaziner J, Macaulay W, Rhoads GG, Sanders D, Noveck H, Dragert K, Forman S, Carson JL, Terrin ML, Magaziner J, Sanders D, Rhoads G, Forman S, Noveck H, Dragert K, Glynn S, Nemo G, Mondoro TH, Barbosa LH, Geller NL, Joo J, Sayers M, Colwell C, Danis M, Lusher J, McLeod B, Reitsma A, Roberson P, Shapiro A, Stone P, Whitsett C, Carson JL, Noveck H, Dragert K, Abad D, Pane P, Raymundo M, Kenny J, Torres C, Affrunti P, Terrin M, Hebel R, Geppi C, Lefever A, Casher E, Buie VC, Hawkes W, Werner-Bronzert M, Golden J, Miller S, McNair T, Smith T, Aro Y, Forman S, Pohl M, Pair T, Yates T, Frey K, Horney RA, Spence E, Carty C, Glassman C, Rhoads M, Pritt S, Yndo B, Buckland H, Lawson K, Dalzell C, Oales HN, Smith J, Chaitman B, Stocke K, Bertram T, Apple F, Murakami MM, Weber D, Beaupre L, Wong-Mah H, Fletcher T, Schaump L, Gidlow I, Haugland M, Kemp K, Woolsey G, Rohloff J, Faulder D, Callendar S, Lewis C, Ademi A, Fish-Furhman J, Cook DR, Gillis A, Rockwell DA, Pedraza H, Frederick D, deAraujo B, Bauer G, Ottaviani R, Pedraza B, Leighton RK, Alexander D, Amirault D, Biddulph M, Coady C, Coles C, Dunbar M, Glazebrook M, Gross M, Johntson D, Oxner W, Reardon G, Richardson G, Stanish W, Dobbin G, Trask K, Ferreira G, Dragert K, Raymundo M, Kenny J, Leddy T, Zawadsky M, Zakriya KJ, Blute MR, Sieber F, Swienckowski J, Colen R, Hawkins C, Sherfey M, Renaud S, Egger N, Lawson D, Dolliver C, Macaulay W, Wong E, Yoon RS, Morrison T, Sheahan M, Nellans K, Nyce J, Sanders D, Tieszer C, McCormack R, Zomar M, Moon K, Munro K, Lemke HM, Klarke D, Matossian S, Lyden JP, Sarmiento M, Wai EK, Vexler L, O'Neil L, Gruszczynski A, Mortensen M, Borsella V, Roffey DM, Ciocon JO, Formoso MM, Thurston P, Belanger HH, Jemmett W, Aarons W, Ong A, White J, Meola K, Roberson J, Simmons AC, Boomgarden C, Burke SL, Montelione A, Paris B, Zagorin A, Born C, Medeiros B, Newman J, Szaro J, Fitzgibbons P, Kupersmith E, McAllister S, Okewole S, Farrell E, Niblack P, Hildebrand KA, Eccles A, Ford K, Gravenstein S, Biedenbender R, Carlton M, Gibson WK, Sutterfield J, Stannard J, Burns B, Ellis S, Waldrop H, Watkins F, Fries R, Gordon M, Kreder HJ, Bulmer B, Gallant A, Crnko N, Chang P, Wright R, Kinnaman K, Balli R, Phy M, Doctolero S, Gausling R, Post J, Vargas B, Knapke D, Lurie M, Hildebrand KA, Jelinski S, Ghali W, Closkey R, Schmidt J, Mendelson D, Bingham K, Friedman SM, Iorio R, Immig R, Garfi J, Scher E, Leon SN, Johnson L, Aaron RK, Bunce G, Davis JM, Morris K, Naudie D, Marr J, Thompson A, Newman N, Paris S, Heroux D, Schemitsch E, Vicente M, Wild L, Orwig D, Werner ML, Fine ML, Sterling R, Andersen D, Heck DA, Kinnaman K.
- 1Division of General Internal Medicine, Department of Medicine, University of Medicine and Dentistry of New Jersey, Robert Wood Johnson Medical School, New Brunswick, NJ 08903, USA. carson@umdnj.edu
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.).
- PMID:
- 22168590
- [PubMed - indexed for MEDLINE]
- PMCID:
- PMC3268062
Free PMC ArticleFigure 1Lowest 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.
N Engl J Med. 2011 December 29;365(26):2453-2462.
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