NCT00366886

Brief Summary

The purpose of this current retrospective study is to perform follow-up analysis on the 22 children from the study # 621-2004 It is important to examine whether an elevated biomarker of brain ischemia before and/or following cardiac surgery has any clinical or functional implications as the child ages.

Trial Health

35
At Risk

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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 Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 17, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 21, 2006

Completed
Last Updated

June 13, 2007

Status Verified

June 1, 2007

First QC Date

August 17, 2006

Last Update Submit

June 12, 2007

Conditions

Keywords

cardiacpediatricsurgeryblood markers

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • participated in previous 621-2004 blood marker study for infants and children having open-heart surgery with cardiopulmonary bypass with or without hypothermic circulatory arrest

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Healthcare of Atlanta

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Janet M Simsic, MD

    Children's Healthcare of Atlanta

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 17, 2006

First Posted

August 21, 2006

Study Completion

July 1, 2006

Last Updated

June 13, 2007

Record last verified: 2007-06

Locations