- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00226369
Cylexin for Reduction of Reperfusion Injury in Infant Heart Surgery
Multicenter, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy/Safety of CY-1503 (Cylexin) in Prevention of Reperfusion Injury in Neonates/Infants Undergoing Hypothermic Cardiopulmonary Bypass
Study Overview
Detailed Description
Study Type
Enrollment
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02115
- Children's Hospital Boston
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria: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 Criteria: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.
-
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
1) non-operative mortality within 30 days, 2) time from ICU admission to extubation, 3) 48-hour Ccr, 4) time to eligibility for ICU discharge, and 5) total inotrope score
|
Secondary Outcome Measures
Outcome Measure |
---|
1) A-a O2 gradient during the first 48 hours 2) total urine output in the first 72 hours, 3) total fluid balance during the first 72 hours, and 4) time to hospital discharge
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jane W Newburger, MD, MPH, Boston Children's Hospital
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- X04-01-007R
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Congenital Heart Defects
-
Oslo University HospitalUniversity of BergenCompletedHeart Septal Defects, Atrial | Heart Defects,CongenitalNorway
-
National Heart, Lung, and Blood Institute (NHLBI)CompletedHeart Diseases | Cardiovascular Diseases | Heart Septal Defects, Atrial | Heart Septal Defects, Ventricular | Endocardial Cushion Defects | Defect, Congenital Heart
-
National Heart, Lung, and Blood Institute (NHLBI)CompletedHeart Diseases | Cardiovascular Diseases | Heart Septal Defects, Atrial | Heart Septal Defects, Ventricular | Endocardial Cushion Defects | Defect, Congenital Heart
-
SeptRx, Inc.UnknownHeart Septal Defects | Heart Defects, Congenital | Foramen Ovale, PatentGermany, France
-
Medtronic Heart ValvesCompletedDysfunctional RVOT Conduits in Patients With Congenital Heart DefectsSpain, United States, Austria, Canada
-
Ain Shams UniversityCompletedHeart Defects, CongenitalEgypt
-
Zhengzhou UniversityNot yet recruitingCongenital Heart DefectChina
-
Children's Hospital of Eastern OntarioHeart and Stroke Foundation of CanadaRecruitingCongenital Heart DefectCanada
-
Medical College of WisconsinNational Center for Research Resources (NCRR); Children's Hospital and Health...Terminated
-
Oslo University HospitalBioPhausiaCompletedHeart Defects, Congenital | Transposition of Great Vessels | Heart Septal Defects, Ventricular | Endocardial Cushion Defects
Clinical Trials on CY-1503
-
Shanghai Jiao Tong University School of MedicineUnknownEffects of ChemotherapyChina
-
Botanix PharmaceuticalsCompletedAcne VulgarisUnited States, Australia
-
Cytavis Biopharma GmbHCompleted
-
Shanghai Jiao Tong University School of MedicineUnknownLymphoblastic Leukemia, Acute, AdultChina
-
Cytavis Biopharma GmbHCharite University, Berlin, Germany; ClinAssess GmbH; Medical University InnsbruckTerminatedMetastatic Colorectal CancerAustria, Germany
-
Fred Hutchinson Cancer CenterRecruiting
-
Peking University People's HospitalRecruitingRefractory Leukemia | Stem Cell Transplant Complications | Relapse LeukemiaChina
-
Peking University People's HospitalRecruitingLeukemia, Myeloid, Acute | Stem Cell Transplant Complications | Leukemia RelapseChina
-
Shanghai Jiao Tong University School of MedicineCompletedLymphoid MalignanciesChina