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Cerebral Perfusion During Neonatal Cardiac Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01032876
Recruitment Status : Completed
First Posted : December 16, 2009
Last Update Posted : June 29, 2012
Information provided by:
UMC Utrecht

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.

Condition or disease Intervention/treatment Phase
Congenital Heart Defects Hypoplastic Left Heart Syndrome Aortic Coarctation Procedure: Deep Hypothermic Circulatory Arrest Procedure: Antegrade Cerebral Perfusion Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Randomized Controlled Trial on Deep Hypothermic Circulatory Arrest Versus Antegrade Cerebral Perfusion During Neonatal Cardiac Surgery
Study Start Date : January 2009
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Arm Intervention/treatment
Experimental: Deep Hypothermic Circulatory Arrest Procedure: Deep Hypothermic Circulatory Arrest
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).

Experimental: Antegrade Cerebral Perfusion Procedure: Antegrade Cerebral Perfusion
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.

Primary Outcome Measures :
  1. New or worsened lesions on postoperative MRI-scan (as compared to pre-operative scan). [ Time Frame: Approximately 1 week postoperatively ]

Secondary Outcome Measures :
  1. Mortality within 30 days [ Time Frame: 30 days postoperatively ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 4 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01032876

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UMC Utrecht
Utrecht, Netherlands
Sponsors and Collaborators
UMC Utrecht
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Principal Investigator: Felix Haas, MD UMC Utrecht

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Prof. F. Haas, UMC Utrecht Identifier: NCT01032876    
Other Study ID Numbers: 08-090/K
First Posted: December 16, 2009    Key Record Dates
Last Update Posted: June 29, 2012
Last Verified: June 2012
Keywords provided by UMC Utrecht:
Congenital Heart disease
Cardiopulmonary bypass
Neonatal brain injury
Deep Hypothermic Circulatory Arrest
Antegrade Cerebral Perfusion
Additional relevant MeSH terms:
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Heart Defects, Congenital
Hypoplastic Left Heart Syndrome
Aortic Coarctation
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities