Cerebrum and Cardiac Protection With Allopurinol in Neonates With Critical Congenital Heart Disease Requiring Cardiac Surgery With Cardiopulmonary Bypass
NCT ID: NCT04217421
Last Updated: 2024-05-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
236 participants
INTERVENTIONAL
2020-02-14
2028-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Allopurinol
Allopurinol
Allopurinol powder for solution for infusion (PFI) 20 mg/kg body weight per administration will be administered early postnatally (within 45 minutes and 12 hours after the first dose), preoperatively (12 hours before surgery), intraoperatively (during surgery) and postoperatively (24 hours after surgery) to the neonate in case of a prenatal CCHD diagnosis. Allopurinol PFI will be administered only pre-, intra- and postoperatively to the neonate in case of a postnatal CCHD diagnosis.
Placebo
Mannitol
Mannitol powder for solution (PFI) placebo will be administered early postnatally (within 45 minutes and 12 hours after birth), preoperatively (12 hours before surgery), intraoperatively (during surgery), and postoperatively (24 hours after surgery) to the neonate in case of a prenatal CCHD diagnosis. Mannitol PFI-placebo will be administered only pre-, intra- and postoperatively to the neonate in case of a postnatal CCHD diagnosis.
Interventions
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Allopurinol
Allopurinol powder for solution for infusion (PFI) 20 mg/kg body weight per administration will be administered early postnatally (within 45 minutes and 12 hours after the first dose), preoperatively (12 hours before surgery), intraoperatively (during surgery) and postoperatively (24 hours after surgery) to the neonate in case of a prenatal CCHD diagnosis. Allopurinol PFI will be administered only pre-, intra- and postoperatively to the neonate in case of a postnatal CCHD diagnosis.
Mannitol
Mannitol powder for solution (PFI) placebo will be administered early postnatally (within 45 minutes and 12 hours after birth), preoperatively (12 hours before surgery), intraoperatively (during surgery), and postoperatively (24 hours after surgery) to the neonate in case of a prenatal CCHD diagnosis. Mannitol PFI-placebo will be administered only pre-, intra- and postoperatively to the neonate in case of a postnatal CCHD diagnosis.
Eligibility Criteria
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Inclusion Criteria
* Informed consent provided by both parents.
Exclusion Criteria
* Doubt whether the aortic arch anomaly before birth requires cardiac surgery with CPB in the neonatal period.
* Gestational age below 36 weeks and/or birth weight less than 2000 gram.
* Surgery not requiring cardiopulmonary bypass.
* Decision for "comfort care only".
1 Month
ALL
No
Sponsors
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ZonMw: The Netherlands Organisation for Health Research and Development
OTHER
University Medical Center Groningen
OTHER
Erasmus Medical Center
OTHER
University Medical Center Nijmegen
OTHER
ACE Pharmaceuticals BV
OTHER
dr. M.J.N.L. Benders
OTHER
Responsible Party
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dr. M.J.N.L. Benders
Professor, Head of Neonatology, MD
Principal Investigators
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Manon JNL Benders, Prof. MD PhD
Role: PRINCIPAL_INVESTIGATOR
University Medical Center Utrecht (UMC Utrecht)
Johannes (Hans) MPJ Breur, MD PhD
Role: PRINCIPAL_INVESTIGATOR
University Medical Center Utrecht (UMC Utrecht)
Nicolaas (Koos) JG Jansen, MD PhD
Role: STUDY_DIRECTOR
University Medical Center Utrecht (UMC Utrecht)
Raymond Stegeman, MD
Role: STUDY_DIRECTOR
University Medical Center Utrecht (UMC Utrecht)
Locations
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University Medical Center Groningen (UMCG)
Groningen, , Netherlands
Radboud University Medical Center Nijmegen (Radboudumc)
Nijmegen, , Netherlands
Erasmus Medical Center Rotterdam (Erasmus MC)
Rotterdam, , Netherlands
University Medical Center Utrecht (UMC Utrecht)
Utrecht, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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Arend F Bos, Prof. MD PhD
Role: primary
Nicolaas (Koos) JG Jansen, MD PhD
Role: backup
Ingrid M van Beynum, MD PhD
Role: primary
Manon JNL Benders, Prof. MD PhD
Role: primary
Maaike Nijman, MD
Role: backup
References
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Stegeman R, Nijman M, Breur JMPJ, Groenendaal F, Haas F, Derks JB, Nijman J, van Beynum IM, Taverne YJHJ, Bogers AJJC, Helbing WA, de Boode WP, Bos AF, Berger RMF, Accord RE, Roes KCB, de Wit GA, Jansen NJG, Benders MJNL; CRUCIAL trial consortium. CeRebrUm and CardIac Protection with ALlopurinol in Neonates with Critical Congenital Heart Disease Requiring Cardiac Surgery with Cardiopulmonary Bypass (CRUCIAL): study protocol of a phase III, randomized, quadruple-blinded, placebo-controlled, Dutch multicenter trial. Trials. 2022 Feb 23;23(1):174. doi: 10.1186/s13063-022-06098-y.
Other Identifiers
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2017-004596-31
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
METC UMCU 18-791
Identifier Type: -
Identifier Source: org_study_id
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