- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01032876
Cerebral Perfusion During Neonatal Cardiac Surgery
Randomized Controlled Trial on Deep Hypothermic Circulatory Arrest Versus Antegrade Cerebral Perfusion During Neonatal Cardiac Surgery
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Utrecht, Netherlands
- UMC Utrecht
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Deep Hypothermic Circulatory Arrest
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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).
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Experimental: Antegrade Cerebral Perfusion
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
New or worsened lesions on postoperative MRI-scan (as compared to pre-operative scan).
Time Frame: Approximately 1 week postoperatively
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Approximately 1 week postoperatively
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Mortality within 30 days
Time Frame: 30 days postoperatively
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30 days postoperatively
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Felix Haas, MD, UMC Utrecht
Publications and helpful links
General Publications
- Algra SO, Jansen NJ, van der Tweel I, Schouten AN, Groenendaal F, Toet M, van Oeveren W, van Haastert IC, Schoof PH, de Vries LS, Haas F. Neurological injury after neonatal cardiac surgery: a randomized, controlled trial of 2 perfusion techniques. Circulation. 2014 Jan 14;129(2):224-33. doi: 10.1161/CIRCULATIONAHA.113.003312. Epub 2013 Oct 20.
- Algra SO, Groeneveld KM, Schadenberg AW, Haas F, Evens FC, Meerding J, Koenderman L, Jansen NJ, Prakken BJ. Cerebral ischemia initiates an immediate innate immune response in neonates during cardiac surgery. J Neuroinflammation. 2013 Feb 7;10:24. doi: 10.1186/1742-2094-10-24.
- Algra SO, Schouten AN, van Oeveren W, van der Tweel I, Schoof PH, Jansen NJ, Haas F. Low-flow antegrade cerebral perfusion attenuates early renal and intestinal injury during neonatal aortic arch reconstruction. J Thorac Cardiovasc Surg. 2012 Dec;144(6):1323-8, 1328.e1-2. doi: 10.1016/j.jtcvs.2012.03.008. Epub 2012 Apr 13.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 08-090/K
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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