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NCT01834976 Clinical Trial

Cardiac Biomarker in Pediatric Heart Disease

Congenital Heart Disease Clinical Trial

Official title:
Observational Study of Cardiac Biomarker During Perioperative Management in Pediatric Heart Disease

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01834976
Other study ID # pchd biomarker in okayama
Secondary ID
Status Completed
Phase N/A
First received April 15, 2013
Last updated December 27, 2015
Start date November 2012
Est. completion date December 2014

Study information
Verified date December 2015
Source Okayama University
Contact n/a
Is FDA regulated No
Health authority Japan: Ministry of Education, Culture, Sports, Science and Technology
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 74
Est. completion date December 2014
Est. primary completion date November 2014
Accepts healthy volunteers No
Gender Both
Age group N/A to 18 Years
Eligibility Inclusion Criteria:

- children who receive surgery for congenital heart disease

- require cardiopulmonary bypass for surgery

- under 18 years old

Exclusion Criteria:

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Japan Okayama University Hospital Okayama

Sponsors (1)
Lead Sponsor Collaborator
Okayama University

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary serious adverse events one month Yes
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