NCT00485745

Brief Summary

Given the relative lack of information regarding the risks associated with repeat sternotomy in the pediatric patient population, a preliminary screen of the Children's Cardiothoracic Surgery Database was performed to determine how many repeat sternotomies have been performed at this institution within the last 4 years. A total of 1281 repeat sternotomies were identified during this time period. We propose a retrospective review of the indications, potential risk factors, and short-term outcomes for these procedures. These data would allow a multivariable regression analysis to identify risk factors associated with adverse events during repeat sternotomy.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
1,281

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2002

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2002

Completed
5.4 years until next milestone

First Submitted

Initial submission to the registry

June 12, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 13, 2007

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

December 2, 2014

Status Verified

November 1, 2014

Enrollment Period

7.8 years

First QC Date

June 12, 2007

Last Update Submit

November 25, 2014

Conditions

Congenital Disorders

Keywords

surgeryrepeat sternotomypediatrics

Outcome Measures

Primary Outcomes (1)

  • Retrospective medical record review evaluating preoperative and intraoperative variables associated with repeat sternotomy as risk factors for adverse events.

    This study will be a retrospective medical record review evaluating preoperative and intraoperative variables associated with repeat sternotomy as risk factors for adverse events. Short-term outcomes including ventilator time, intensive care unit and hospital length of stay, blood product utilization, and transfusions will be analyzed to determine the effect of adverse events.

    Length of stay

Eligibility Criteria

AgeUp to 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

The study population for this retrospective chart review will be all patients, under 21 years of age who have undergone a repeat sternotomy at Children's Healthcare of Atlanta at Egleston between January 1, 2002 and December 31, 2006. A repeat sternotomy is defined as having been performed more than a month after the most recent previous sternotomy.

You may qualify if:

  • Repeat sternotomy at Children's Healthcare of Atlanta between 1.1.02 and 12.31.06
  • patient under 21 years of age
  • "repeat" is defined as a sternotomy performed more than 1 month after the most recent previous sternotomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Paul M Kirshbom, MD

    Children's Healthcare of Atlanta

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

June 12, 2007

First Posted

June 13, 2007

Study Start

January 1, 2002

Primary Completion

November 1, 2009

Study Completion

November 1, 2009

Last Updated

December 2, 2014

Record last verified: 2014-11