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Clinical Trials/ISRCTN93129502
ISRCTN93129502
Completed
未知

A randomised controlled trial to compare normothermic versus hypothermic cardiopulmonary bypass in children undergoing open heart surgery

niversity Hospitals Bristol NHS Foundation Trust (UK)0 sites110 target enrollmentFebruary 27, 2009

Overview

Phase
未知
Intervention
Not specified
Conditions
Not specified
Sponsor
niversity Hospitals Bristol NHS Foundation Trust (UK)
Enrollment
110
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

  1. 2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26007621 (added 27/05/2015) 2. 2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/30322847 (added 07/05/2019)
Registry
who.int
Start Date
February 27, 2009
End Date
April 1, 2016
Last Updated
6 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
niversity Hospitals Bristol NHS Foundation Trust (UK)

Eligibility Criteria

Inclusion Criteria

  • Current inclusion criteria as of 15/05/2015:
  • Participant may enter study if ALL of the following apply:
  • 1\. Patients undergoing congenital heart operations not requiring deep hypothermic circulatory arrest
  • 2\. Patients aged \=17 years of age
  • Previous inclusion criteria:
  • 1\. Female and male patients from birth upwards (there is no upper age limit, per se)
  • 2\. Treated at the Bristol Royal Hospital for Children
  • 3\. Undergoing congenital heart operations not requiring deep hypothermic circulatory arrest

Exclusion Criteria

  • Participant may not enter study if ANY of the following apply
  • 1\. Emergency operations (patients with haemodynamic instability who require immediate surgical intervention)
  • 2\. Patients requiring hypothermic circulatory arrest

Outcomes

Primary Outcomes

Not specified

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