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Cerebral Perfusion During Neonatal Cardiac Surgery

Primary Purpose

Congenital Heart Defects, Hypoplastic Left Heart Syndrome, Aortic Coarctation

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Deep Hypothermic Circulatory Arrest
Antegrade Cerebral Perfusion
Sponsored by
UMC Utrecht
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Congenital Heart Defects focused on measuring Congenital Heart disease, Cardiopulmonary bypass, Neonatal brain injury, Deep Hypothermic Circulatory Arrest, Antegrade Cerebral Perfusion

Eligibility Criteria

undefined - 4 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UMC Utrecht

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Deep Hypothermic Circulatory Arrest

Antegrade Cerebral Perfusion

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Mortality within 30 days

Full Information

First Posted
December 15, 2009
Last Updated
June 28, 2012
Sponsor
UMC Utrecht
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1. Study Identification

Unique Protocol Identification Number
NCT01032876
Brief Title
Cerebral Perfusion During Neonatal Cardiac Surgery
Official Title
Randomized Controlled Trial on Deep Hypothermic Circulatory Arrest Versus Antegrade Cerebral Perfusion During Neonatal Cardiac Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
UMC Utrecht

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Heart Defects, Hypoplastic Left Heart Syndrome, Aortic Coarctation
Keywords
Congenital Heart disease, Cardiopulmonary bypass, Neonatal brain injury, Deep Hypothermic Circulatory Arrest, Antegrade Cerebral Perfusion

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Deep Hypothermic Circulatory Arrest
Arm Type
Experimental
Arm Title
Antegrade Cerebral Perfusion
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Deep Hypothermic Circulatory Arrest
Intervention Description
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).
Intervention Type
Procedure
Intervention Name(s)
Antegrade Cerebral Perfusion
Intervention Description
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 Measure Information:
Title
New or worsened lesions on postoperative MRI-scan (as compared to pre-operative scan).
Time Frame
Approximately 1 week postoperatively
Secondary Outcome Measure Information:
Title
Mortality within 30 days
Time Frame
30 days postoperatively

10. Eligibility

Sex
All
Maximum Age & Unit of Time
4 Months
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Felix Haas, MD
Organizational Affiliation
UMC Utrecht
Official's Role
Principal Investigator
Facility Information:
Facility Name
UMC Utrecht
City
Utrecht
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
24141323
Citation
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.
Results Reference
derived
PubMed Identifier
23390999
Citation
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.
Results Reference
derived
PubMed Identifier
22503201
Citation
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.
Results Reference
derived

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Cerebral Perfusion During Neonatal Cardiac Surgery

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