Randomized trial of hematocrit 25% versus 35% during hypothermic cardiopulmonary bypass in infant heart surgery

Newburger, Jane W.; Jonas, Richard A.; Soul, Janet; Kussman, Barry D.; Bellinger, David C.; Laussen, Peter C.; Robertson, Richard; Mayer, John E.; del Nido, Pedro J.; Bacha, Emile A.; Forbess, Joseph M.; Pigula, Frank; Roth, Stephen J.; Visconti, Karen J.; du Plessis, Adre J.; Farrell, David M.; McGrath, Ellen; Rappaport, Leonard A.; Wypij, David

doi:10.1016/j.jtcvs.2007.01.051

« Previous Next »The Journal of Thoracic and Cardiovascular Surgery
Volume 135, Issue 2 , Pages 347-354.e4, February 2008

Randomized trial of hematocrit 25% versus 35% during hypothermic cardiopulmonary bypass in infant heart surgery

Jane W. Newburger, MD, MPH
- Department of Cardiology, Children’s Hospital Boston, Boston, Mass
- Department of Pediatrics, Harvard Medical School, Boston, Mass
- Address for reprints: Jane W. Newburger, MD, MPH, Department of Cardiology, Children’s Hospital Boston, 300 Longwood Ave, Boston, MA 02115.
Richard A. Jonas, MD
- Department of Cardiovascular Surgery, Children’s Hospital Boston, Boston, Mass
- Department of Surgery, Harvard Medical School, Boston, Mass
- Dr Jonas is currently Chief of Cardiovascular Surgery and Co-director of the Children’s National Heart Institute, Washington, DC.
Janet Soul, MD
- Department of Neurology, Children’s Hospital Boston, Boston, Mass
- Department of Neurology, Harvard Medical School, Boston, Mass
Barry D. Kussman, MBBCh
- Department of Anesthesiology, Children’s Hospital Boston, Boston, Mass
- Department of Anesthesia, Harvard Medical School, Boston, Mass
David C. Bellinger, PhD, MSc
- Department of Neurology, Children’s Hospital Boston, Boston, Mass
- Department of Neurology, Harvard Medical School, Boston, Mass
Peter C. Laussen, MD
- Department of Cardiology, Children’s Hospital Boston, Boston, Mass
- Department of Anesthesia, Harvard Medical School, Boston, Mass
Richard Robertson, MD
- Department of Radiology, Children’s Hospital Boston, Boston, Mass
- Department of Radiology Harvard Medical School, Boston, Mass
John E. Mayer Jr, MD
- Department of Cardiovascular Surgery, Children’s Hospital Boston, Boston, Mass
- Department of Surgery, Harvard Medical School, Boston, Mass
Pedro J. del Nido, MD
- Department of Cardiovascular Surgery, Children’s Hospital Boston, Boston, Mass
- Department of Surgery, Harvard Medical School, Boston, Mass
Emile A. Bacha, MD
- Department of Cardiovascular Surgery, Children’s Hospital Boston, Boston, Mass
- Department of Surgery, Harvard Medical School, Boston, Mass
Joseph M. Forbess, MD
- Department of Cardiovascular Surgery, Children’s Hospital Boston, Boston, Mass
- Department of Surgery, Harvard Medical School, Boston, Mass
- Dr Forbess is currently at Children’s Medical Center Dallas.
Frank Pigula, MD
- Department of Cardiovascular Surgery, Children’s Hospital Boston, Boston, Mass
Stephen J. Roth, MD, MPH
- Department of Cardiology, Children’s Hospital Boston, Boston, Mass
Karen J. Visconti, PhD
- Department of Cardiovascular Surgery, Children’s Hospital Boston, Boston, Mass
Adre J. du Plessis, MBChB, MPH
- Department of Neurology, Children’s Hospital Boston, Boston, Mass
- Department of Neurology, Harvard Medical School, Boston, Mass
David M. Farrell, MA, CCP
- Department of Cardiovascular Surgery, Children’s Hospital Boston, Boston, Mass
Ellen McGrath, RN
- Department of Cardiology, Children’s Hospital Boston, Boston, Mass
Leonard A. Rappaport, MD
- Department of Pediatrics, Children’s Hospital Boston, Boston, Mass
- Department of Pediatrics, Harvard Medical School, Boston, Mass
David Wypij, PhD
- Department of Cardiology, Children’s Hospital Boston, Boston, Mass
- Department of Pediatrics, Harvard Medical School, Boston, Mass
- Department of Biostatistics, Harvard School of Public Health, Boston, Mass.

Received 11 October 2006; received in revised form 9 January 2007; accepted 29 January 2007.

Objectives

We previously reported that postoperative hemodynamics and developmental outcomes were better among infants randomized to a higher hematocrit value during hypothermic cardiopulmonary bypass. However, worse outcomes were concentrated in patients with hematocrit values of 20% or below, and the benefits of hematocrit values higher than 25% were uncertain.

Methods

We compared perioperative hemodynamics and, at 1 year, developmental outcome and brain magnetic resonance imaging in a single-center, randomized trial of hemodilution to a hematocrit value of 25% versus 35% during hypothermic radiopulmonary bypass for reparative heart surgery in infants undergoing 2-ventricle repairs without aortic arch obstruction.

Results

Among 124 subjects, 56 were assigned to the lower-hematocrit strategy (24.8% ± 3.1%, mean ± SD) and 68 to the higher-hematocrit strategy (32.6% ± 3.5%). Infants randomized to the 25% strategy, compared with the 35% strategy, had a more positive intraoperative fluid balance (P = .007) and lower regional cerebral oxygen saturation at 10 minutes after cooling (P = .04) and onset of low flow (P = .03). Infants with dextro-transposition of the great arteries in the 25% group had significantly longer hospital stay. Other postoperative outcomes, blood product usage, and adverse events were similar in the treatment groups. At age 1 year (n = 106), the treatment groups had similar scores on the Psychomotor and Mental Development Indexes of the Bayley Scales; both groups scored significantly worse than population norms.

Conclusions

Hemodilution to hematocrit levels of 35% compared with those of 25% had no major benefits or risks overall among infants undergoing 2-ventricle repair. Developmental outcomes at age 1 year in both randomized groups were below those in the normative population.

CTSNet classification: 19, 20, 21, 25

Abbreviations and Acronyms: CPB, cardiopulmonary bypass, d-TGA, dextro-transposition of the great arteries, DTI, diffusion tensor imaging, MDI, Mental Development Index, MRI, magnetic resonance imaging, MRS, magnetic resonance spectroscopy, PDI, Psychomotor Development Index, PRISM, Pediatric Risk of Mortality, TOF, tetralogy of Fallot, VSD, ventricular septal defect

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Registered with clinicaltrials.gov (#) NCT00006183

Supported by grants HL 063411 and RR 02172 from the National Institutes of Health and by the Farb Family Fund.

PII: S0022-5223(07)00299-1

doi:10.1016/j.jtcvs.2007.01.051

Refers to article:

Improving neurologic and quality-of-life outcomes in children with congenital heart disease: Past, present, and future
Gil Wernovsky
The Journal of Thoracic and Cardiovascular Surgery February 2008 (Vol. 135, Issue 2, Pages 240-242.e2)
- Full Text
- PDF (80 KB)
The effect of hematocrit during hypothermic cardiopulmonary bypass in infant heart surgery: Results from the combined Boston hematocrit trials
David Wypij, Richard A. Jonas, David C. Bellinger, Pedro J. Del Nido, John E. Mayer, Emile A. Bacha, Joseph M. Forbess, Frank Pigula, Peter C. Laussen, Jane W. Newburger
The Journal of Thoracic and Cardiovascular Surgery February 2008 (Vol. 135, Issue 2, Pages 355-360)