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Restrictive Versus Liberal Transfusion Strategies for Older Mechanically Ventilated Critically Ill Patients: A Randomized Pilot Trial*

Walsh, Timothy S. MD1; Boyd, Julia A. PhD2; Watson, Douglas MSc3; Hope, David Pg Dip1; Lewis, Steff PhD4; Krishan, Ashma MSc2,4; Forbes, John F. PhD4; Ramsay, Pamela PhD1; Pearse, Rupert MD5; Wallis, Charles FRCA6; Cairns, Christopher FRCA7; Cole, Stephen FRCA8; Wyncoll, Duncan FRCA9

doi: 10.1097/CCM.0b013e318291cce4
Clinical Investigations

Objectives: To compare hemoglobin concentration (Hb), RBC use, and patient outcomes when restrictive or liberal blood transfusion strategies are used to treat anemic (Hb ≤ 90 g/L) critically ill patients of age ≥ 55 years requiring ≥ 4 days of mechanical ventilation in ICU.

Design: Parallel-group randomized multicenter pilot trial.

Setting: Six ICUs in the United Kingdom participated between August 2009 and December 2010.

Patients: One hundred patients (51 restrictive and 49 liberal groups).

Interventions: Patients were randomized to a restrictive (Hb trigger, 70 g/L; target, 71–90 g/L) or liberal (90 g/L; target, 91–110 g/L) transfusion strategy for 14 days or the remainder of ICU stay, whichever was longest.

Measurements and Main Results: Baseline comorbidity rates and illness severity were high, notably for ischemic heart disease (32%). The Hb difference among groups was 13.8 g/L (95% CI, 11.5–16.0 g/L); p < 0.0001); mean Hb during intervention was 81.9 (SD, 5.1) versus 95.7 (6.3) g/L; 21.6% fewer patients in the restrictive group were transfused postrandomization (p < 0.001) and received a median 1 (95% CI, 1–2; p = 0.002) fewer RBC units. Protocol compliance was high. No major differences in organ dysfunction, duration of ventilation, infections, or cardiovascular complications were observed during intensive care and hospital follow-up. Mortality at 180 days postrandomization trended toward higher rates in the liberal group (55%) than in the restrictive group (37%); relative risk was 0.68 (95% CI, 0.44–1.05; p = 0.073). This trend remained in a survival model adjusted for age, gender, ischemic heart disease, Acute Physiology and Chronic Health Evaluation II score, and total non-neurologic Sequential Organ Failure Assessment score at baseline (hazard ratio, 0.54 [95% CI, 0.28–1.03]; p = 0.061).

Conclusions: A large trial of transfusion strategies in older mechanically ventilated patients is feasible. This pilot trial found a nonsignificant trend toward lower mortality with restrictive transfusion practice.

1Department of Critical Care and Centre for Inflammation Research, Edinburgh University, Little France Crescent, Edinburgh, Scotland.

2Edinburgh Clinical Trials Unit, Western General Hospital, Edinburgh, Scotland.

3Better Blood Transfusion, National Blood Transfusion Service, Gartnavel, Glasgow, Scotland.

4Centre for Population Health Sciences, Edinburgh University, Edinburgh, Scotland.

5Barts and The London School of Medicine & Dentistry, Queen Marys University of London, London, UK.

6Department of Anaesthesia and Intensive Care, Western General Hospital, Crewe Toll, Edinburgh, Scotland.

7Department of Anaesthetics, Stirling Royal Infirmary, Stirling, Scotland.

8Department of Anaesthesia and Critical Care, Ninewells Hospital & Medical School, Dundee, Scotland.

9Guy’s & St Thomas’ NHS Foundation Trust, London, UK.

* See also p. 2450.

Trial registration: Clinicaltrials.gov NCT00944112.

This work was led by Edinburgh University and the Edinburgh Clinical Trials Unit.

Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal’s website (http://journals.lww.com/ccmjournal).

Supported, in part, by the Chief Scientists Office, Scotland (CZB/4/698); the Scottish National Blood Transfusion Service, the NHS Lothian Academic Health Science Centre; and the Transfusion Medicine Education and Research Foundation. These funders had no direct influence or role in design and conduct of the study; collection, management, analysis, or interpretation of the data; or preparation, review, or approval of the article.

Dr. Walsh has consulted for GE Healthcare and has received grant support from National Institute of Healthcare Research (NIHR) Health Technology Agency. Dr. Boyd received travel reimbursements and grant support from Chief Scientists Office. Dr. Lewis has given expert testimony for Merck and has received grant support from Medical Research Council (MRC)/Chief Scientists Office, Scotland (CSO)/ Arthritis Research UK (ARUK)/etc. Dr. Wyncoll received grant support from Chief Scientists Office, Scotland and Health Technology Assessment 09/144/51; reimbursement for travel to Edinburgh (setup and close out meeting); served as a board member for Astellas and Covidien; consulted for Convatec and Baxter; lectured for Astellas, Eli Lilly, Pfizer, Sage Products Inc, Iskus Health, and Smiths/Portex; received payment for development of educational presentations from Astellas; and has stock options in Biovo Technologies). Drs. Watson, Hope, Krishan, Forbes, Ramsay, Wallis, Cairns, and Cole received grant support from Chief Scientists Office, Scotland. Dr. Pearse received grant support from Chief Scientists Office and is a National Institute for Health Research (UK) Clinician Scientist.

For information regarding this article, E-mail: twalsh@staffmail.ed.ac.uk

© 2013 by the Society of Critical Care Medicine and Lippincott Williams & Wilkins