NL-OMON52736RecruitingPhase 3
CeRebrUm and CardIac protection with Allopurinol in neonates with critical congenital heart disease requiring cardiac surgery with cardiopulmonary bypass - CRUCIAL-TRIA
niversitair Medisch Centrum Utrecht0 sites236 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Enrollment
- 236
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 0 to 1 (—)
Inclusion Criteria
- •Neonates with a prenatally or postnatally confirmed diagnosis of CCHD requiring
- •(anticipated) cardiac surgery with CBP within the first 4 weeks of life are
- •eligible for inclusion. This includes neonates with the following cardiac
- •defects 1) Transposition of the great arteries with or without a ventricular
- •septal defect undergoing arterial switch operation with ventricular septal
- •defect closure if needed; 2) Univentricular hearts: hypoplastic left and right
- •heart syndrome, or variant undergoing Norwood Stage I or Sano palliation; 3)
- •Aortic arch anomalies: interrupted, hypoplastic aortic arch and/or coarctation
- •of the aorta with or without intracardiac defects (ventricular/atrial septal
- •defect, or (sub)aortic stenosis) who undergo complete biventricular repair
- •and/or aortic arch repair; 4) Other variants: truncus arteriosus, total
- •anomalous pulmonary venous connection, or tetralogy of Fallot. Written informed
- •consent of both parents is required prior to inclusion.
Exclusion Criteria
- •- Inability to enroll the patient before the start of delivery in case of
- •prenatal diagnosis, or 24 hours before surgery in case of postnatal diagnosis.
- •- Doubt whether the aortic arch anomaly before birth requires cardiac surgery
- •with CPB in the neonatal
- •- Gestational
- •age below 36 weeks and/or birth weight less than 2000 gram.
- •- Surgery not requiring cardiopulmonary
- •- Patient considered
- •*moribund*.
- •- Decision for *comfort care only*.
Investigators
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