An interventional study of Deep Hypothermic Circulatory Arrest and Antegrade Cerebral Perfusion in Congenital Heart Defects, Hypoplastic Left Heart Syndrome and Aortic Coarctation, sponsored by UMC Utrecht. Completed at 1 site in Netherlands. Open to participants aged Up to 4 Months. Per ClinicalTrials.gov, last updated 2012-06-29.
Sponsored by UMC Utrecht · Not applicable, Interventional, and Prevention
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.
991 studies on the registry are indexed under Heart Defects, Congenital; 251 are open to participants now.
This study's enrollment of 37 is below the median of 60 across 507 interventional studies indexed under Heart Defects, Congenital.
Browse Heart Defects, Congenital studies →UMC Utrecht is the lead sponsor of 364 studies on the registry; 82 are open to participants now.
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Exclusion Criteria:
Procedure: Deep Hypothermic Circulatory Arrest
Procedure: Antegrade Cerebral Perfusion
DHCA will be employed for a maximum of 60 minutes. If more time (\>60 min) is needed for the arch reconstruction the surgeon will proceed with ACP, which will be continued for the rest of the operation (= DHCA+ACP).
One cannula will be advanced into the brachiocephalic/ innominate artery via the usual arterial cannulation site in the aorta ascendens. A flow of 20-25% of the maximum CPB-flow will be used, which corresponds to a flow rate of 40-50 ml/ kg/ min.
New or worsened lesions on postoperative MRI-scan (as compared to pre-operative scan).
Time frame: Approximately 1 week postoperatively
Mortality within 30 days
Time frame: 30 days postoperatively
This study is completed, as verified in Jun 2012. You cannot join it, but the record below documents what was studied.
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