Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00226369
Status:
COMPLETED
Last Update Posted:
2010-02-12
First Post:
2005-09-21
Brief Title:
Cylexin for Reduction of Reperfusion Injury in Infant Heart Surgery
Sponsor:
Boston Childrens Hospital
Organization:
Boston Childrens Hospital
Study Overview
Official Title:
Multicenter Double-Blind Placebo-Controlled Study to Evaluate EfficacySafety of CY-1503 Cylexin in Prevention of Reperfusion Injury in NeonatesInfants Undergoing Hypothermic Cardiopulmonary Bypass
Status:
COMPLETED
Status Verified Date:
2005-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 undergoing hypothermic cardiopulmonary bypass during surgical repair or palliation of congenital heart defects
Detailed Description:
Ischemiareperfusion IR 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 IR injury following hypothermic CPB Entry criteria included age at surgery 1-45 days birth weight 23 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-TGA90 VSD16 TOFtruncus22 TAPVR9 VSD with aortic arch obstruction18 and 75 for stage 1 palliation Group 2 single ventricle with aortic arch obstruction Of those enrolled 117 were assigned to Cylexin Group 180 Group 247 and 113 to placebo Group 175 Group 238 Pre- and intraoperative variables were comparable between treatment groups Early 30 day mortality for Cylexin versus placebo patients in Group 1 was 0 versus 38 p025 and for Group 2 was 108 versus 289 p008 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 IR injury in high-risk infants
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None