Comparison of Hematocrit Levels in Infant Heart Surgery
Hematocrit Strategy in Infant Heart Surgery
2 other identifiers
interventional
120
1 country
1
Brief Summary
The purpose of this study is to compare the effects of diluted hematocrit (HCT) levels of 35% versus 25% during hypothermic cardiopulmonary bypass (CPB) in infants with d-transposition of the great arteries, a malformation of the heart vessels.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 cardiovascular-diseases
Started Jul 2000
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2000
CompletedFirst Submitted
Initial submission to the registry
August 21, 2000
CompletedFirst Posted
Study publicly available on registry
August 22, 2000
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2005
CompletedJuly 29, 2016
March 1, 2008
5 years
August 21, 2000
July 28, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
Serum lactate levels (measured 1 hour after surgery)
Developmental outcome (measured by Bayley Scales of Infant Development at age 1 year)
Secondary Outcomes (8)
Duration of postoperative endotracheal intubation, ICU stay, and hospital stay
PaO2/FiO2 ratio
Levels of circulating pro-inflammatory cytokines
Percent change in total body water, as estimated by bioelectrical impedance (measured 1 hour after surgery)
Tissue release of S-100 protein as a measure of cerebral cellular injury
- +3 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- Undergoing repair of ventricular septal defect within 9 months of study entry
- Tetralogy of fallot
- D-transposition of the great arteries
- Atrio-ventricular septal defect
You may not qualify if:
- Birth weight less than 2.3 kg
- Recognizable phenotypic syndrome of congenital anomalies
- Extracardiac anomalies of greater than minor severity
- Previous cardiac surgery
- Associated cardiovascular anomalies requiring aortic arch reconstruction or additional open surgical procedures before the planned developmental follow-up
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Children's Hospital
Boston, Massachusetts, 02115, United States
Related Publications (8)
Jonas RA, Wypij D, Roth SJ, Bellinger DC, Visconti KJ, du Plessis AJ, Goodkin H, Laussen PC, Farrell DM, Bartlett J, McGrath E, Rappaport LJ, Bacha EA, Forbess JM, del Nido PJ, Mayer JE Jr, Newburger JW. The influence of hemodilution on outcome after hypothermic cardiopulmonary bypass: results of a randomized trial in infants. J Thorac Cardiovasc Surg. 2003 Dec;126(6):1765-74. doi: 10.1016/j.jtcvs.2003.04.003.
PMID: 14688685BACKGROUNDBassan H, Gauvreau K, Newburger JW, Tsuji M, Limperopoulos C, Soul JS, Walter G, Laussen PC, Jonas RA, du Plessis AJ. Identification of pressure passive cerebral perfusion and its mediators after infant cardiac surgery. Pediatr Res. 2005 Jan;57(1):35-41. doi: 10.1203/01.PDR.0000147576.84092.F9. Epub 2004 Nov 5.
PMID: 15531739BACKGROUNDKussman BD, Wypij D, DiNardo JA, Newburger J, Jonas RA, Bartlett J, McGrath E, Laussen PC. An evaluation of bilateral monitoring of cerebral oxygen saturation during pediatric cardiac surgery. Anesth Analg. 2005 Nov;101(5):1294-1300. doi: 10.1213/01.ANE.0000180205.85490.85.
PMID: 16243983BACKGROUNDRollins CK, Asaro LA, Akhondi-Asl A, Kussman BD, Rivkin MJ, Bellinger DC, Warfield SK, Wypij D, Newburger JW, Soul JS. White Matter Volume Predicts Language Development in Congenital Heart Disease. J Pediatr. 2017 Feb;181:42-48.e2. doi: 10.1016/j.jpeds.2016.09.070. Epub 2016 Nov 9.
PMID: 27837950DERIVEDKussman BD, Wypij D, Laussen PC, Soul JS, Bellinger DC, DiNardo JA, Robertson R, Pigula FA, Jonas RA, Newburger JW. Relationship of intraoperative cerebral oxygen saturation to neurodevelopmental outcome and brain magnetic resonance imaging at 1 year of age in infants undergoing biventricular repair. Circulation. 2010 Jul 20;122(3):245-54. doi: 10.1161/CIRCULATIONAHA.109.902338. Epub 2010 Jul 6.
PMID: 20606124DERIVEDKipps AK, Wypij D, Thiagarajan RR, Bacha EA, Newburger JW. Blood transfusion is associated with prolonged duration of mechanical ventilation in infants undergoing reparative cardiac surgery. Pediatr Crit Care Med. 2011 Jan;12(1):52-6. doi: 10.1097/PCC.0b013e3181e30d43.
PMID: 20453699DERIVEDSoul JS, Robertson RL, Wypij D, Bellinger DC, Visconti KJ, du Plessis AJ, Kussman BD, Scoppettuolo LA, Pigula F, Jonas RA, Newburger JW. Subtle hemorrhagic brain injury is associated with neurodevelopmental impairment in infants with repaired congenital heart disease. J Thorac Cardiovasc Surg. 2009 Aug;138(2):374-81. doi: 10.1016/j.jtcvs.2009.02.027. Epub 2009 Apr 10.
PMID: 19619781DERIVEDNewburger JW, Jonas RA, Soul J, Kussman BD, Bellinger DC, Laussen PC, Robertson R, Mayer JE Jr, del Nido PJ, Bacha EA, Forbess JM, Pigula F, Roth SJ, Visconti KJ, du Plessis AJ, Farrell DM, McGrath E, Rappaport LA, Wypij D. Randomized trial of hematocrit 25% versus 35% during hypothermic cardiopulmonary bypass in infant heart surgery. J Thorac Cardiovasc Surg. 2008 Feb;135(2):347-54, 354.e1-4. doi: 10.1016/j.jtcvs.2007.01.051.
PMID: 18242267DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jane W. Newburger, MD, MPH
Children's Hospital Medical Center, Cincinnati
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
Study Record Dates
First Submitted
August 21, 2000
First Posted
August 22, 2000
Study Start
July 1, 2000
Primary Completion
July 1, 2005
Study Completion
July 1, 2005
Last Updated
July 29, 2016
Record last verified: 2008-03