Cylexin for Reduction of Reperfusion Injury in Infant Heart Surgery

Phase

2/3

Condition

Organ Transplant

Pentalogy Of Cantrell

Treatment

N/A

Clinical Study ID

NCT00226369

X04-01-007R

Ages < 45
All Genders

Study 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 undergoing hypothermic cardiopulmonary bypass during surgical repair or palliation of congenital heart defects.

Eligibility Criteria

Inclusion

Inclusion Criteria:1) scheduled cardiac surgery with hypothermic CPB to repair eitherD-transposition of the great arteries (D-TGA) with intact ventricular septum (IVS) orventricular septal defect (VSD), VSD with or without aortic arch obstruction (AAO),tetralogy of Fallot (TOF) with or without pulmonary atresia (PA), truncus arteriosus, totalanomalous pulmonary venous return (TAPVR), or double outlet right ventricle (DORV), or topalliate 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) birthweight > 2.3 kg, and 4) a cranial ultrasound < 1 week prior to enrollment showing at mostgrade II hemorrhage in high risk patients -

Exclusion

Exclusion Criteria:Exclusion criteria included the following: 1) need for urgent cardiacsurgery, 2) cardiac arrest ≤ 1 week before surgery, 3) prior procedure with hypothermicCPB, 4) acute or chronic infection, 5) major noncardiac congenital anomalies or chromosomalabnormalities, 6) preoperative arterial pH ≤ 7.0, 7) any significant noncardiac organdysfunction such as renal failure, respiratory failure, seizures, or necrotizingenterocolitis, and 8) use of another investigational drug.

Study Design

December 01, 1997

June 30, 2001

Study 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, double-blinded trial of the leukocyte-endothelial cell adhesion inhibitor Cylexin in young infants to determine if it reduces I/R injury following hypothermic CPB. Entry criteria included age at surgery 1-45 days, birth weight > 2.3 kg, and planned repair or palliation of congenital heart defects with CPB. We excluded patients with specified antecedent events or conditions, including lung or kidney disease, seizures, necrotizing enterocolitis, infection, or other serious noncardiac morbidity. Randomization was stratified by study center and cardiac diagnosis. Cylexin was administered continuously from sternotomy until 24 hours post CPB. Centers followed their usual operative and postoperative care practices. From December 1997-March 1999, we enrolled 230 infants, 155 for 2-ventricle repairs (Group 1: D-TGA=90, VSD=16, TOF/truncus=22, TAPVR=9, VSD with aortic arch obstruction=18) and 75 for stage 1 palliation (Group 2: single ventricle with aortic arch obstruction). Of those enrolled, 117 were assigned to Cylexin (Group 1=80, Group 2=47) and 113 to placebo (Group 1=75, Group 2=38). Pre- and intraoperative variables were comparable between treatment groups. Early (30 day) mortality for Cylexin versus placebo patients in Group 1 was 0% versus 3.8% (p=0.25) and for Group 2 was 10.8% versus 28.9% (p=0.08). In both risk groups, treatment with Cylexin did not significantly improve other early postoperative outcomes or decrease the occurrence of adverse events. Cylexin did not significantly improve early mortality or postoperative recovery in Group 1 patients. Despite a small sample size, early mortality in Group 2 Cylexin-treated patients tended to be lower, suggesting the need for future trials of agents that could reduce I/R injury in high-risk infants.

Connect with a study center

Children's Hospital Boston
Boston, Massachusetts 02115
United States
Site Not Available

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