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Richard A. Jonas
Peter C. Laussen
John E. Mayer, Jr
Pedro J. del Nido
Emile A. Bacha
Joseph M. Forbess
Frank Pigula
Ellen McGrath
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J Thorac Cardiovasc Surg 2008;135:347-354
© 2008 The American Association for Thoracic Surgery

Surgery for Congenital Heart Disease

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

Jane W. Newburger, MD, MPHa,h,*, Richard A. Jonas, MDb,g,*, Janet Soul, MDc,j, Barry D. Kussman, MBBChd,i, David C. Bellinger, PhD, MScc,j, Peter C. Laussen, MDa,i, Richard Robertson, MDe,k, John E. Mayer, Jr, MDb,g, Pedro J. del Nido, MDb,g, Emile A. Bacha, MDb,g, Joseph M. Forbess, MDb,g,{dagger}, Frank Pigula, MDb, Stephen J. Roth, MD, MPHa, Karen J. Visconti, PhDb, Adre J. du Plessis, MBChB, MPHc,j, David M. Farrell, MA, CCPb, Ellen McGrath, RNa, Leonard A. Rappaport, MDf,h, David Wypij, PhDa,h,l

a Department of Cardiology, Children’s Hospital Boston, Boston, Mass
b Department of Cardiovascular Surgery, Children’s Hospital Boston, Boston, Mass
c Department of Neurology, Children’s Hospital Boston, Boston, Mass
d Department of Anesthesiology, Children’s Hospital Boston, Boston, Mass
e Department of Radiology, Children’s Hospital Boston, Boston, Mass
f Department of Pediatrics, Children’s Hospital Boston, Boston, Mass
g Department of Surgery, Harvard Medical School, Boston, Mass
h Department of Pediatrics, Harvard Medical School, Boston, Mass
i Department of Anesthesia, Harvard Medical School, Boston, Mass
j Department of Neurology, Harvard Medical School, Boston, Mass
k Department of Radiology Harvard Medical School, Boston, Mass
l Department of Biostatistics, Harvard School of Public Health, Boston, Mass.

Received for publication October 11, 2006; revisions received January 9, 2007; accepted for publication January 29, 2007.

* Address for reprints: Jane W. Newburger, MD, MPH, Department of Cardiology, Children’s Hospital Boston, 300 Longwood Ave, Boston, MA 02115. (Email: jane.newburger{at}cardio.chboston.org).

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.

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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