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

Jeffrey L Carson, Michael L Terrin, Helaine Noveck, David W Sanders, Bernard R Chaitman, George G Rhoads, George Nemo, Karen Dragert, Lauren Beaupre, Kevin Hildebrand, William Macaulay, Courtland Lewis, Donald Richard Cook, Gwendolyn Dobbin, Khwaja J Zakriya, Fred S Apple, Rebecca A Horney, Jay Magaziner, FOCUS Investigators, Jeffrey L Carson, Michael L Terrin, Lauren Beaupre, Bernard R Chaitman, Gwendolyn Dobbin, Lee A Fleisher, A Gerson Greenburg, Paul C Hébert, David A Heck, Kevin A Hildebrand, Harold Kaplan, Courtland Lewis, Jay Magaziner, William Macaulay, George G Rhoads, David Sanders, Helaine Noveck, Karen Dragert, Sandra Forman, Jeffrey L Carson, Michael L Terrin, Jay Magaziner, David Sanders, George Rhoads, Sandy Forman, Helaine Noveck, Karen Dragert, Simone Glynn, George Nemo, Traci Heath Mondoro, Luiz H Barbosa, Nancy L Geller, Jungnam Joo, Merlyn Sayers, Clifford Colwell, Marion Danis, Jeanne Lusher, Bruce McLeod, Angelique Reitsma, Paula Roberson, Amy Shapiro, Peter Stone, Carolyn Whitsett, Jeffrey L Carson, Helaine Noveck, Karen Dragert, Diana Abad, Pat Pane, Maricar Raymundo, Judy Kenny, Carolina Torres, Pat Affrunti, Michael Terrin, Richard Hebel, Cindy Geppi, Andrea Lefever, Elizabeth Casher, Verita Custis Buie, William Hawkes, Michelle Werner-Bronzert, Justine Golden, Sue Miller, Tamara McNair, Tiffany Smith, Yvonne Aro, Sandra Forman, Mark Pohl, Tamar Pair, Teresa Yates, Kristin Frey, Rebecca Anne Horney, Elizabeth Spence, Christina Carty, Connie Glassman, Maxine Rhoads, Sandra Pritt, Barbara Yndo, Heather Buckland, Karen Lawson, Christine Dalzell, Howard Norman Oales, Jennifer Smith, Bernard Chaitman, Karen Stocke, Teri Bertram, Fred Apple, MaryAnn M Murakami, Don Weber, Lauren Beaupre, Holly Wong-Mah, Twyla Fletcher, Lori Schaump, Ivanna Gidlow, Michele Haugland, Kyle Kemp, Guy Woolsey, Jacqueline Rohloff, Doug Faulder, Stella Callendar, Courtland Lewis, Arben Ademi, Jamie Fish-Furhman, Donald R Cook, Annette Gillis, David A Rockwell, Hector Pedraza, Dave Frederick, Bill deAraujo, Greg Bauer, Rob Ottaviani, Beverly Pedraza, Ross K Leighton, David Alexander, David Amirault, Michael Biddulph, Cathy Coady, Chad Coles, Michael Dunbar, Mark Glazebrook, Michael Gross, David Johntson, William Oxner, Gerald Reardon, Glen Richardson, William Stanish, Gwendolyn Dobbin, Kelly Trask, Gabriella Ferreira, Karen Dragert, Maricar Raymundo, Judy Kenny, Timothy Leddy, Mark Zawadsky, Khwaja J Zakriya, Mary-Rita Blute, Frederick Sieber, John Swienckowski, Robert Colen, Cyndi Hawkins, Michael Sherfey, Stefan Renaud, Norman Egger, Donna Lawson, Cherrie Dolliver, William Macaulay, Eugene Wong, Richard S Yoon, Todd Morrison, Maureen Sheahan, Kate Nellans, Jonathan Nyce, David Sanders, Christina Tieszer, Robert McCormack, Mauri Zomar, Karyn Moon, Karen Munro, H Michael Lemke, Dorrit Klarke, Sebouh Matossian, John P Lyden, Maliza Sarmiento, Eugene K Wai, Liisa Vexler, Liz O'Neil, Adam Gruszczynski, Melodie Mortensen, Vivian Borsella, Darren M Roffey, Jerry O Ciocon, Milagros Mitos Formoso, Peter Thurston, Heather Hrushowy Belanger, Wendy Jemmett, William Aarons, Alvin Ong, Jackie White, Kathleen Meola, James Roberson, Adam C Simmons, Clint Boomgarden, Sally Lashley Burke, Anita Montelione, Barbara Paris, Aleksandra Zagorin, Christopher Born, Beverly Medeiros, June Newman, Jeannette Szaro, Peter Fitzgibbons, Eric Kupersmith, Susan McAllister, Simon Okewole, Eric Farrell, Patricia Niblack, Kevin A Hildebrand, Audrey Eccles, Kim Ford, Stefan Gravenstein, Rex Biedenbender, Melissa Carlton, Wilford Keith Gibson, Juliann Sutterfield, James Stannard, Becky Burns, Sharon Ellis, Holly Waldrop, Franklin Watkins, Rose Fries, Michelle Gordon, Hans J Kreder, Bev Bulmer, Aimee Gallant, Naomi Crnko, Paul Chang, Ruth Wright, Kathy Kinnaman, Rudolph Balli, Michael Phy, Susan Doctolero, Rudolph Gausling, Janisse Post, Bibiana Vargas, Donald Knapke, Melissa Lurie, Kevin A Hildebrand, Shelly Jelinski, William Ghali, Robert Closkey, Judy Schmidt, Daniel Mendelson, Karilee Bingham, Susan M Friedman, Richard Iorio, Rosemary Immig, John Garfi, Eric Scher, Shaun Nicole Leon, Latoyia Johnson, Roy K Aaron, Gail Bunce, John Mihran Davis, Kimo Morris, Doug Naudie, Juliana Marr, Abigail Thompson, Nicholas Newman, Suzanne Paris, Denise Heroux, Emil Schemitsch, Milena Vicente, Lisa Wild, Denise Orwig, Michelle L Werner, Mary Louise Fine, Robert Sterling, Daniel Andersen, David A Heck, Kathleen Kinnaman, Jeffrey L Carson, Michael L Terrin, Helaine Noveck, David W Sanders, Bernard R Chaitman, George G Rhoads, George Nemo, Karen Dragert, Lauren Beaupre, Kevin Hildebrand, William Macaulay, Courtland Lewis, Donald Richard Cook, Gwendolyn Dobbin, Khwaja J Zakriya, Fred S Apple, Rebecca A Horney, Jay Magaziner, FOCUS Investigators, Jeffrey L Carson, Michael L Terrin, Lauren Beaupre, Bernard R Chaitman, Gwendolyn Dobbin, Lee A Fleisher, A Gerson Greenburg, Paul C Hébert, David A Heck, Kevin A Hildebrand, Harold Kaplan, Courtland Lewis, Jay Magaziner, William Macaulay, George G Rhoads, David Sanders, Helaine Noveck, Karen Dragert, Sandra Forman, Jeffrey L Carson, Michael L Terrin, Jay Magaziner, David Sanders, George Rhoads, Sandy Forman, Helaine Noveck, Karen Dragert, Simone Glynn, George Nemo, Traci Heath Mondoro, Luiz H Barbosa, Nancy L Geller, Jungnam Joo, Merlyn Sayers, Clifford Colwell, Marion Danis, Jeanne Lusher, Bruce McLeod, Angelique Reitsma, Paula Roberson, Amy Shapiro, Peter Stone, Carolyn Whitsett, Jeffrey L Carson, Helaine Noveck, Karen Dragert, Diana Abad, Pat Pane, Maricar Raymundo, Judy Kenny, Carolina Torres, Pat Affrunti, Michael Terrin, Richard Hebel, Cindy Geppi, Andrea Lefever, Elizabeth Casher, Verita Custis Buie, William Hawkes, Michelle Werner-Bronzert, Justine Golden, Sue Miller, Tamara McNair, Tiffany Smith, Yvonne Aro, Sandra Forman, Mark Pohl, Tamar Pair, Teresa Yates, Kristin Frey, Rebecca Anne Horney, Elizabeth Spence, Christina Carty, Connie Glassman, Maxine Rhoads, Sandra Pritt, Barbara Yndo, Heather Buckland, Karen Lawson, Christine Dalzell, Howard Norman Oales, Jennifer Smith, Bernard Chaitman, Karen Stocke, Teri Bertram, Fred Apple, MaryAnn M Murakami, Don Weber, Lauren Beaupre, Holly Wong-Mah, Twyla Fletcher, Lori Schaump, Ivanna Gidlow, Michele Haugland, Kyle Kemp, Guy Woolsey, Jacqueline Rohloff, Doug Faulder, Stella Callendar, Courtland Lewis, Arben Ademi, Jamie Fish-Furhman, Donald R Cook, Annette Gillis, David A Rockwell, Hector Pedraza, Dave Frederick, Bill deAraujo, Greg Bauer, Rob Ottaviani, Beverly Pedraza, Ross K Leighton, David Alexander, David Amirault, Michael Biddulph, Cathy Coady, Chad Coles, Michael Dunbar, Mark Glazebrook, Michael Gross, David Johntson, William Oxner, Gerald Reardon, Glen Richardson, William Stanish, Gwendolyn Dobbin, Kelly Trask, Gabriella Ferreira, Karen Dragert, Maricar Raymundo, Judy Kenny, Timothy Leddy, Mark Zawadsky, Khwaja J Zakriya, Mary-Rita Blute, Frederick Sieber, John Swienckowski, Robert Colen, Cyndi Hawkins, Michael Sherfey, Stefan Renaud, Norman Egger, Donna Lawson, Cherrie Dolliver, William Macaulay, Eugene Wong, Richard S Yoon, Todd Morrison, Maureen Sheahan, Kate Nellans, Jonathan Nyce, David Sanders, Christina Tieszer, Robert McCormack, Mauri Zomar, Karyn Moon, Karen Munro, H Michael Lemke, Dorrit Klarke, Sebouh Matossian, John P Lyden, Maliza Sarmiento, Eugene K Wai, Liisa Vexler, Liz O'Neil, Adam Gruszczynski, Melodie Mortensen, Vivian Borsella, Darren M Roffey, Jerry O Ciocon, Milagros Mitos Formoso, Peter Thurston, Heather Hrushowy Belanger, Wendy Jemmett, William Aarons, Alvin Ong, Jackie White, Kathleen Meola, James Roberson, Adam C Simmons, Clint Boomgarden, Sally Lashley Burke, Anita Montelione, Barbara Paris, Aleksandra Zagorin, Christopher Born, Beverly Medeiros, June Newman, Jeannette Szaro, Peter Fitzgibbons, Eric Kupersmith, Susan McAllister, Simon Okewole, Eric Farrell, Patricia Niblack, Kevin A Hildebrand, Audrey Eccles, Kim Ford, Stefan Gravenstein, Rex Biedenbender, Melissa Carlton, Wilford Keith Gibson, Juliann Sutterfield, James Stannard, Becky Burns, Sharon Ellis, Holly Waldrop, Franklin Watkins, Rose Fries, Michelle Gordon, Hans J Kreder, Bev Bulmer, Aimee Gallant, Naomi Crnko, Paul Chang, Ruth Wright, Kathy Kinnaman, Rudolph Balli, Michael Phy, Susan Doctolero, Rudolph Gausling, Janisse Post, Bibiana Vargas, Donald Knapke, Melissa Lurie, Kevin A Hildebrand, Shelly Jelinski, William Ghali, Robert Closkey, Judy Schmidt, Daniel Mendelson, Karilee Bingham, Susan M Friedman, Richard Iorio, Rosemary Immig, John Garfi, Eric Scher, Shaun Nicole Leon, Latoyia Johnson, Roy K Aaron, Gail Bunce, John Mihran Davis, Kimo Morris, Doug Naudie, Juliana Marr, Abigail Thompson, Nicholas Newman, Suzanne Paris, Denise Heroux, Emil Schemitsch, Milena Vicente, Lisa Wild, Denise Orwig, Michelle L Werner, Mary Louise Fine, Robert Sterling, Daniel Andersen, David A Heck, Kathleen Kinnaman

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.).

Conflict of interest statement

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

Figures

Figure 1. Lowest Daily Hemoglobin Levels
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.

Source: PubMed

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