NCT01032876

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

December 15, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 16, 2009

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

June 29, 2012

Status Verified

June 1, 2012

Enrollment Period

3.4 years

First QC Date

December 15, 2009

Last Update Submit

June 28, 2012

Conditions

Congenital Heart DefectsHypoplastic Left Heart SyndromeAortic Coarctation

Keywords

Congenital Heart diseaseCardiopulmonary bypassNeonatal brain injuryDeep Hypothermic Circulatory ArrestAntegrade Cerebral Perfusion

Outcome Measures

Primary Outcomes (1)

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

    Approximately 1 week postoperatively

Secondary Outcomes (1)

  • Mortality within 30 days

    30 days postoperatively

Study Arms (2)

Deep Hypothermic Circulatory Arrest

EXPERIMENTAL
Procedure: Deep Hypothermic Circulatory Arrest

Antegrade Cerebral Perfusion

EXPERIMENTAL
Procedure: Antegrade Cerebral Perfusion

Interventions

Deep Hypothermic Circulatory ArrestPROCEDURE

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).

Deep Hypothermic Circulatory Arrest
Antegrade Cerebral PerfusionPROCEDURE

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.

Antegrade Cerebral Perfusion

Eligibility Criteria

AgeUp to 4 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UMC Utrecht

Utrecht, Netherlands

Location

Related Publications (3)

  • 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.

    PMID: 24141323DERIVED

  • 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.

    PMID: 23390999DERIVED

  • 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.

    PMID: 22503201DERIVED

MeSH Terms

Conditions

Heart Defects, CongenitalHypoplastic Left Heart SyndromeAortic Coarctation

Interventions

Circulatory Arrest, Deep Hypothermia Induced

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Heart Arrest, InducedCardiac Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeThoracic Surgical Procedures

Study Officials

  • Felix Haas, MD

    UMC Utrecht

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 15, 2009

First Posted

December 16, 2009

Study Start

January 1, 2009

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

June 29, 2012

Record last verified: 2012-06

Locations

NL(1)