NCT00226369

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
242

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 1997

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

December 1, 1997

Completed
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2001

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

September 21, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 27, 2005

Completed
Last Updated

February 12, 2010

Status Verified

September 1, 2005

First QC Date

September 21, 2005

Last Update Submit

February 11, 2010

Conditions

Congenital Heart Defects

Keywords

PediatricCardiopulmonary bypassCongenital heart diseaseReperfusion injury

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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

Interventions

CY-1503DRUG

Eligibility Criteria

AgeUp to 45 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital Boston

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Heart Defects, CongenitalReperfusion Injury

Interventions

CY 1503

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesVascular DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jane W Newburger, MD, MPH

    Boston Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 21, 2005

First Posted

September 27, 2005

Study Start

December 1, 1997

Study Completion

June 1, 2001

Last Updated

February 12, 2010

Record last verified: 2005-09

Locations

US(1)