Liberal versus restrictive blood transfusion strategy

3-year survival and cause of death results from the FOCUS randomised controlled trial

Jeffrey L. Carson, Frederick Sieber, Donald Richard Cook, Donald R. Hoover, Helaine Noveck, Bernard R. Chaitman, Lee Fleisher, Lauren Beaupre, William Macaulay, George G. Rhoads, Barbara Paris, Aleksandra Zagorin, David W. Sanders, Khwaja J. Zakriya, Jay Magaziner

Research output: Contribution to journalArticle

Abstract

Summary Background Blood transfusion might affect long-term mortality by changing immune function and thus potentially increasing the risk of subsequent infections and cancer recurrence. Compared with a restrictive transfusion strategy, a more liberal strategy could reduce cardiac complications by lowering myocardial damage, thereby reducing future deaths from cardiovascular disease. We aimed to establish the effect of a liberal transfusion strategy on long-term survival compared with a restrictive transfusion strategy. Methods In the randomised controlled FOCUS trial, adult patients aged 50 years and older, with a history of or risk factors for cardiovascular disease, and with postoperative haemoglobin concentrations lower than 100 g/L within 3 days of surgery to repair a hip fracture, were eligible for enrolment. Patients were recruited from 47 participating hospitals in the USA and Canada, and eligible participants were randomly allocated in a 1:1 ratio by a central telephone system to either liberal transfusion in which they received blood transfusion to maintain haemoglobin level at 100 g/L or higher, or restrictive transfusion in which they received blood transfusion when haemoglobin level was lower than 80 g/L or if they had symptoms of anaemia. In this study, we analysed the long-term mortality of patients assigned to the two transfusion strategies, which was a secondary outcome of the FOCUS trial. Long-term mortality was established by linking the study participants to national death registries in the USA and Canada. Treatment assignment was not masked, but investigators who ascertained mortality and cause of death were masked to group assignment. Analyses were by intention to treat. The FOCUS trial is registered with ClinicalTrials.gov, number NCT00071032. Findings Between July 19, 2004, and Feb 28, 2009, 2016 patients were enrolled and randomly assigned to the two treatment groups: 1007 to the liberal transfusion strategy and 1009 to the restrictive transfusion strategy. The median duration of follow-up was 3·1 years (IQR 2·4-4·1 years), during which 841 (42%) patients died. Long-term mortality did not differ significantly between the liberal transfusion strategy (432 deaths) and the restrictive transfusion strategy (409 deaths) (hazard ratio 1·09 [95% CI 0·95-1·25]; p=0·21). Interpretation Liberal blood transfusion did not affect mortality compared with a restrictive transfusion strategy in a high-risk group of elderly patients with underlying cardiovascular disease or risk factors. The underlying causes of death did not differ between the trial groups. These findings do not support hypotheses that blood transfusion leads to long-term immunosuppression that is severe enough to affect long-term mortality rate by more than 20-25% or cause of death. Funding National Heart, Lung, and Blood Institute.

Original languageEnglish (US)
Article number62286
Pages (from-to)1183-1189
Number of pages7
JournalThe Lancet
Volume385
Issue number9974
DOIs
StatePublished - Mar 28 2015

Fingerprint

Blood Transfusion
Cause of Death
Randomized Controlled Trials
Survival
Mortality
Hemoglobins
Cardiovascular Diseases
Canada
National Heart, Lung, and Blood Institute (U.S.)
Intention to Treat Analysis
Hip Fractures
Ambulatory Surgical Procedures
Telephone
Immunosuppression
Registries
Anemia
Research Personnel
Recurrence
Therapeutics
Infection

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Liberal versus restrictive blood transfusion strategy : 3-year survival and cause of death results from the FOCUS randomised controlled trial. / Carson, Jeffrey L.; Sieber, Frederick; Cook, Donald Richard; Hoover, Donald R.; Noveck, Helaine; Chaitman, Bernard R.; Fleisher, Lee; Beaupre, Lauren; Macaulay, William; Rhoads, George G.; Paris, Barbara; Zagorin, Aleksandra; Sanders, David W.; Zakriya, Khwaja J.; Magaziner, Jay.

In: The Lancet, Vol. 385, No. 9974, 62286, 28.03.2015, p. 1183-1189.

Research output: Contribution to journalArticle

Carson, JL, Sieber, F, Cook, DR, Hoover, DR, Noveck, H, Chaitman, BR, Fleisher, L, Beaupre, L, Macaulay, W, Rhoads, GG, Paris, B, Zagorin, A, Sanders, DW, Zakriya, KJ & Magaziner, J 2015, 'Liberal versus restrictive blood transfusion strategy: 3-year survival and cause of death results from the FOCUS randomised controlled trial', The Lancet, vol. 385, no. 9974, 62286, pp. 1183-1189. https://doi.org/10.1016/S0140-6736(14)62286-8
Carson, Jeffrey L. ; Sieber, Frederick ; Cook, Donald Richard ; Hoover, Donald R. ; Noveck, Helaine ; Chaitman, Bernard R. ; Fleisher, Lee ; Beaupre, Lauren ; Macaulay, William ; Rhoads, George G. ; Paris, Barbara ; Zagorin, Aleksandra ; Sanders, David W. ; Zakriya, Khwaja J. ; Magaziner, Jay. / Liberal versus restrictive blood transfusion strategy : 3-year survival and cause of death results from the FOCUS randomised controlled trial. In: The Lancet. 2015 ; Vol. 385, No. 9974. pp. 1183-1189.
@article{d2ab9ce8a7584667aeb2e2e192021709,
title = "Liberal versus restrictive blood transfusion strategy: 3-year survival and cause of death results from the FOCUS randomised controlled trial",
abstract = "Summary Background Blood transfusion might affect long-term mortality by changing immune function and thus potentially increasing the risk of subsequent infections and cancer recurrence. Compared with a restrictive transfusion strategy, a more liberal strategy could reduce cardiac complications by lowering myocardial damage, thereby reducing future deaths from cardiovascular disease. We aimed to establish the effect of a liberal transfusion strategy on long-term survival compared with a restrictive transfusion strategy. Methods In the randomised controlled FOCUS trial, adult patients aged 50 years and older, with a history of or risk factors for cardiovascular disease, and with postoperative haemoglobin concentrations lower than 100 g/L within 3 days of surgery to repair a hip fracture, were eligible for enrolment. Patients were recruited from 47 participating hospitals in the USA and Canada, and eligible participants were randomly allocated in a 1:1 ratio by a central telephone system to either liberal transfusion in which they received blood transfusion to maintain haemoglobin level at 100 g/L or higher, or restrictive transfusion in which they received blood transfusion when haemoglobin level was lower than 80 g/L or if they had symptoms of anaemia. In this study, we analysed the long-term mortality of patients assigned to the two transfusion strategies, which was a secondary outcome of the FOCUS trial. Long-term mortality was established by linking the study participants to national death registries in the USA and Canada. Treatment assignment was not masked, but investigators who ascertained mortality and cause of death were masked to group assignment. Analyses were by intention to treat. The FOCUS trial is registered with ClinicalTrials.gov, number NCT00071032. Findings Between July 19, 2004, and Feb 28, 2009, 2016 patients were enrolled and randomly assigned to the two treatment groups: 1007 to the liberal transfusion strategy and 1009 to the restrictive transfusion strategy. The median duration of follow-up was 3·1 years (IQR 2·4-4·1 years), during which 841 (42{\%}) patients died. Long-term mortality did not differ significantly between the liberal transfusion strategy (432 deaths) and the restrictive transfusion strategy (409 deaths) (hazard ratio 1·09 [95{\%} CI 0·95-1·25]; p=0·21). Interpretation Liberal blood transfusion did not affect mortality compared with a restrictive transfusion strategy in a high-risk group of elderly patients with underlying cardiovascular disease or risk factors. The underlying causes of death did not differ between the trial groups. These findings do not support hypotheses that blood transfusion leads to long-term immunosuppression that is severe enough to affect long-term mortality rate by more than 20-25{\%} or cause of death. Funding National Heart, Lung, and Blood Institute.",
author = "Carson, {Jeffrey L.} and Frederick Sieber and Cook, {Donald Richard} and Hoover, {Donald R.} and Helaine Noveck and Chaitman, {Bernard R.} and Lee Fleisher and Lauren Beaupre and William Macaulay and Rhoads, {George G.} and Barbara Paris and Aleksandra Zagorin and Sanders, {David W.} and Zakriya, {Khwaja J.} and Jay Magaziner",
year = "2015",
month = "3",
day = "28",
doi = "10.1016/S0140-6736(14)62286-8",
language = "English (US)",
volume = "385",
pages = "1183--1189",
journal = "The Lancet",
issn = "0140-6736",
publisher = "Elsevier Limited",
number = "9974",

}

TY - JOUR

T1 - Liberal versus restrictive blood transfusion strategy

T2 - 3-year survival and cause of death results from the FOCUS randomised controlled trial

AU - Carson, Jeffrey L.

AU - Sieber, Frederick

AU - Cook, Donald Richard

AU - Hoover, Donald R.

AU - Noveck, Helaine

AU - Chaitman, Bernard R.

AU - Fleisher, Lee

AU - Beaupre, Lauren

AU - Macaulay, William

AU - Rhoads, George G.

AU - Paris, Barbara

AU - Zagorin, Aleksandra

AU - Sanders, David W.

AU - Zakriya, Khwaja J.

AU - Magaziner, Jay

PY - 2015/3/28

Y1 - 2015/3/28

N2 - Summary Background Blood transfusion might affect long-term mortality by changing immune function and thus potentially increasing the risk of subsequent infections and cancer recurrence. Compared with a restrictive transfusion strategy, a more liberal strategy could reduce cardiac complications by lowering myocardial damage, thereby reducing future deaths from cardiovascular disease. We aimed to establish the effect of a liberal transfusion strategy on long-term survival compared with a restrictive transfusion strategy. Methods In the randomised controlled FOCUS trial, adult patients aged 50 years and older, with a history of or risk factors for cardiovascular disease, and with postoperative haemoglobin concentrations lower than 100 g/L within 3 days of surgery to repair a hip fracture, were eligible for enrolment. Patients were recruited from 47 participating hospitals in the USA and Canada, and eligible participants were randomly allocated in a 1:1 ratio by a central telephone system to either liberal transfusion in which they received blood transfusion to maintain haemoglobin level at 100 g/L or higher, or restrictive transfusion in which they received blood transfusion when haemoglobin level was lower than 80 g/L or if they had symptoms of anaemia. In this study, we analysed the long-term mortality of patients assigned to the two transfusion strategies, which was a secondary outcome of the FOCUS trial. Long-term mortality was established by linking the study participants to national death registries in the USA and Canada. Treatment assignment was not masked, but investigators who ascertained mortality and cause of death were masked to group assignment. Analyses were by intention to treat. The FOCUS trial is registered with ClinicalTrials.gov, number NCT00071032. Findings Between July 19, 2004, and Feb 28, 2009, 2016 patients were enrolled and randomly assigned to the two treatment groups: 1007 to the liberal transfusion strategy and 1009 to the restrictive transfusion strategy. The median duration of follow-up was 3·1 years (IQR 2·4-4·1 years), during which 841 (42%) patients died. Long-term mortality did not differ significantly between the liberal transfusion strategy (432 deaths) and the restrictive transfusion strategy (409 deaths) (hazard ratio 1·09 [95% CI 0·95-1·25]; p=0·21). Interpretation Liberal blood transfusion did not affect mortality compared with a restrictive transfusion strategy in a high-risk group of elderly patients with underlying cardiovascular disease or risk factors. The underlying causes of death did not differ between the trial groups. These findings do not support hypotheses that blood transfusion leads to long-term immunosuppression that is severe enough to affect long-term mortality rate by more than 20-25% or cause of death. Funding National Heart, Lung, and Blood Institute.

AB - Summary Background Blood transfusion might affect long-term mortality by changing immune function and thus potentially increasing the risk of subsequent infections and cancer recurrence. Compared with a restrictive transfusion strategy, a more liberal strategy could reduce cardiac complications by lowering myocardial damage, thereby reducing future deaths from cardiovascular disease. We aimed to establish the effect of a liberal transfusion strategy on long-term survival compared with a restrictive transfusion strategy. Methods In the randomised controlled FOCUS trial, adult patients aged 50 years and older, with a history of or risk factors for cardiovascular disease, and with postoperative haemoglobin concentrations lower than 100 g/L within 3 days of surgery to repair a hip fracture, were eligible for enrolment. Patients were recruited from 47 participating hospitals in the USA and Canada, and eligible participants were randomly allocated in a 1:1 ratio by a central telephone system to either liberal transfusion in which they received blood transfusion to maintain haemoglobin level at 100 g/L or higher, or restrictive transfusion in which they received blood transfusion when haemoglobin level was lower than 80 g/L or if they had symptoms of anaemia. In this study, we analysed the long-term mortality of patients assigned to the two transfusion strategies, which was a secondary outcome of the FOCUS trial. Long-term mortality was established by linking the study participants to national death registries in the USA and Canada. Treatment assignment was not masked, but investigators who ascertained mortality and cause of death were masked to group assignment. Analyses were by intention to treat. The FOCUS trial is registered with ClinicalTrials.gov, number NCT00071032. Findings Between July 19, 2004, and Feb 28, 2009, 2016 patients were enrolled and randomly assigned to the two treatment groups: 1007 to the liberal transfusion strategy and 1009 to the restrictive transfusion strategy. The median duration of follow-up was 3·1 years (IQR 2·4-4·1 years), during which 841 (42%) patients died. Long-term mortality did not differ significantly between the liberal transfusion strategy (432 deaths) and the restrictive transfusion strategy (409 deaths) (hazard ratio 1·09 [95% CI 0·95-1·25]; p=0·21). Interpretation Liberal blood transfusion did not affect mortality compared with a restrictive transfusion strategy in a high-risk group of elderly patients with underlying cardiovascular disease or risk factors. The underlying causes of death did not differ between the trial groups. These findings do not support hypotheses that blood transfusion leads to long-term immunosuppression that is severe enough to affect long-term mortality rate by more than 20-25% or cause of death. Funding National Heart, Lung, and Blood Institute.

UR - http://www.scopus.com/inward/record.url?scp=84926086663&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84926086663&partnerID=8YFLogxK

U2 - 10.1016/S0140-6736(14)62286-8

DO - 10.1016/S0140-6736(14)62286-8

M3 - Article

VL - 385

SP - 1183

EP - 1189

JO - The Lancet

JF - The Lancet

SN - 0140-6736

IS - 9974

M1 - 62286

ER -