Status:
COMPLETED
Cylexin for Reduction of Reperfusion Injury in Infant Heart Surgery
Lead Sponsor:
Boston Children's Hospital
Conditions:
Congenital Heart Defects
Eligibility:
All Genders
Up to 45 years
Phase:
PHASE2
PHASE3
Brief Summary
We conducted a multicenter, randomized, placebo-controlled trial of Cylexin, an inhibitor of the attachment of white blood cells to the endothelium. Our study population was neonates and infants under...
Detailed Description
Ischemia/reperfusion (I/R) injury is an important adverse effect of cardiopulmonary bypass (CPB) in infants undergoing cardiac surgery. We performed a multicenter, randomized, placebo-controlled, doub...
Eligibility Criteria
Inclusion
- 1) scheduled cardiac surgery with hypothermic CPB to repair either D-transposition of the great arteries (D-TGA) with intact ventricular septum (IVS) or ventricular septal defect (VSD), VSD with or without aortic arch obstruction (AAO), tetralogy of Fallot (TOF) with or without pulmonary atresia (PA), truncus arteriosus, total anomalous pulmonary venous return (TAPVR), or double outlet right ventricle (DORV), or to palliate hypoplastic left heart syndrome (HLHS) or other forms of single ventricle (SV) with AAO using the stage I (Norwood) operation, 2) age 1-45 days at surgery, 3) birth weight \> 2.3 kg, and 4) a cranial ultrasound \< 1 week prior to enrollment showing at most grade II hemorrhage in high risk patients -
Exclusion
- Exclusion criteria included the following: 1) need for urgent cardiac surgery, 2) cardiac arrest ≤ 1 week before surgery, 3) prior procedure with hypothermic CPB, 4) acute or chronic infection, 5) major noncardiac congenital anomalies or chromosomal abnormalities, 6) preoperative arterial pH ≤ 7.0, 7) any significant noncardiac organ dysfunction such as renal failure, respiratory failure, seizures, or necrotizing enterocolitis, and 8) use of another investigational drug.
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Key Trial Info
Start Date :
December 1 1997
Trial Type :
INTERVENTIONAL
End Date :
June 1 2001
Estimated Enrollment :
242 Patients enrolled
Trial Details
Trial ID
NCT00226369
Start Date
December 1 1997
End Date
June 1 2001
Last Update
February 12 2010
Active Locations (1)
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1
Children's Hospital Boston
Boston, Massachusetts, United States, 02115