Cerebrum and Cardiac Protection With Allopurinol in Neonates With Critical Congenital Heart Disease Requiring Cardiac Surgery With Cardiopulmonary Bypass (CRUCIAL)

dr. M.J.N.L. Benders

Status and phase

Enrolling

Phase 3

Conditions

Congenital Heart Disease in Children

Neuroprotection

Treatments

Drug: Allopurinol

Drug: Mannitol

Study type

Interventional

Funder types

Other

Identifiers

NCT04217421

2017-004596-31 (EudraCT Number)

METC UMCU 18-791

Details and patient eligibility

About

Neurodevelopmental impairment due to delayed brain development and brain injury is a fundamental problem in children with critical congenital heart disease (CCHD). Significant longterm motor-, cognitive-, and behavioral problems are the result of early postnatally and perioperatively induced brain injury. Allopurinol, a xanthine oxidase inhibitor, prevents the formation of toxic free oxygen radicals, thereby limiting hypoxia-reperfusion damage. Both animal and neonatal studies suggest that administration of allopurinol reduces hypoxic-ischemic brain injury, is cardioprotective, and safe. This study aims to evaluate the efficacy and safety of allopurinol administered early postnatally and perioperatively in children with a CCHD requiring cardiac surgery with cardiopulmonary bypass.

Enrollment

236 estimated patients

Sex

All

Ages

Under 1 month old

Volunteers

No Healthy Volunteers

Inclusion criteria

Neonates with a prenatally or postnatally confirmed diagnosis of CCHD requiring (anticipated) cardiac surgery with CPB within the first 4 weeks of life.
Informed consent provided by both parents.

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 period.
Gestational age below 36 weeks and/or birth weight less than 2000 gram.
Surgery not requiring cardiopulmonary bypass.
Decision for "comfort care only".