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Clinical Trials/NCT01032876
NCT01032876
Completed
Not Applicable

Randomized Controlled Trial on Deep Hypothermic Circulatory Arrest Versus Antegrade Cerebral Perfusion During Neonatal Cardiac Surgery

UMC Utrecht1 site in 1 country37 target enrollmentJanuary 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Congenital Heart Defects
Sponsor
UMC Utrecht
Enrollment
37
Locations
1
Primary Endpoint
New or worsened lesions on postoperative MRI-scan (as compared to pre-operative scan).
Status
Completed
Last Updated
13 years ago

Overview

Brief Summary

Neonates with a congenital heart defect are often in need of early cardiac surgery. In complex congenital heart defects, cardiopulmonary bypass is usually employed, with or without deep hypothermic circulatory arrest (DHCA). The brain is especially vulnerable to ischemic injury, which puts neonates undergoing complex operations at high risk of neurodevelopmental disorders. Selective antegrade cerebral perfusion (ACP) instead of DHCA during these complex operations may contribute to less cerebral damage, but literature is not conclusive on this issue.

Therefore, the investigators will perform a randomised controlled trial comparing DHCA and ACP in neonatal aortic arch reconstructions, focusing on cerebral damage and neurological outcome.

Registry
clinicaltrials.gov
Start Date
January 2009
End Date
June 2012
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Aortic arch reconstruction (diagnosis of hypoplastic left heart syndrome, hypoplastic aortic arch, severe coarctation and/ or interrupted aortic arch)
  • Infants \<4 months old

Exclusion Criteria

  • Anticipated arch reconstruction time longer than 60 minutes
  • Sedation and intubation especially for the pre-operative MRI-scan of this research project
  • Participation in another clinical trial
  • Failure of data collection

Outcomes

Primary Outcomes

New or worsened lesions on postoperative MRI-scan (as compared to pre-operative scan).

Time Frame: Approximately 1 week postoperatively

Secondary Outcomes

  • Mortality within 30 days(30 days postoperatively)

Study Sites (1)

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