NCT01834976

Brief Summary

The purpose of this study is to investigate cardiac biomarker during perioperative management in pediatric cardiac surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
74

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2012

Typical duration 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

November 1, 2012

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 15, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 18, 2013

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

December 29, 2015

Status Verified

December 1, 2015

Enrollment Period

2 years

First QC Date

April 15, 2013

Last Update Submit

December 27, 2015

Conditions

Congenital Heart Disease

Keywords

cardiac biomarkercongenital heart diseasesurgery

Outcome Measures

Primary Outcomes (1)

  • serious adverse events

    one month

Eligibility Criteria

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

pediatric patients who receive surgery for congenital heart disease under 18 years old

You may qualify if:

  • children who receive surgery for congenital heart disease
  • require cardiopulmonary bypass for surgery
  • under 18 years old

You may not qualify if:

  • simple congenital heart disease (atrial septal defect, ventricle septal defect, patent ductus arteriosus)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Okayama University Hospital

Okayama, Okayama-ken, 7008558, Japan

Location

Biospecimen

Retention: SAMPLES WITH DNA

serum,urine

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pediatric cardiac surgery investigators

Study Record Dates

First Submitted

April 15, 2013

First Posted

April 18, 2013

Study Start

November 1, 2012

Primary Completion

November 1, 2014

Study Completion

December 1, 2014

Last Updated

December 29, 2015

Record last verified: 2015-12

Locations

JP(1)