NCT00328146

Brief Summary

Re-operative surgery in children is extremely challenging and injury to the underlying cardiac structures can occur during sternal re-entry. When institution of cardiopulmonary bypass is required in an emergency, there are often limited sites for peripheral cannulation. Injury to the heart can easily result in catastrophic complications and death.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
802

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2001

Longer than P75 for all trials

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

February 1, 2001

Completed
5.3 years until next milestone

First Submitted

Initial submission to the registry

May 18, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 19, 2006

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

March 1, 2017

Status Verified

February 1, 2017

Enrollment Period

8.7 years

First QC Date

May 18, 2006

Last Update Submit

February 27, 2017

Conditions

Congenital Disorders

Keywords

pediatriccardiacre-operative surgery

Outcome Measures

Primary Outcomes (1)

  • Present an effective techniqe for sternal re-entry in children.

Study Arms (1)

Observation of Sternal Re-entry

All subjects.

Other: Observation of sternal reentry

Interventions

Observation of sternal reentryOTHER

Observation of sternal reentry

Observation of Sternal Re-entry

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Any child undergoing re-operative cardiac surgery through a midline sternotomy incision. This is a chart review.

You may qualify if:

  • Any child undergoing re-operative cardiac surgery through a midline sternotomy incision

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

  • Brian E Kogon, MD

    Children's Healthcare of Atlanta

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2006

First Posted

May 19, 2006

Study Start

February 1, 2001

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

March 1, 2017

Record last verified: 2017-02

Locations

US(1)