NCT04217421 (CRUCIAL) is a Phase 3 clinical trial of Allopurinol in Congenital Heart Disease in Children, sponsored by dr. M.J.N.L. Benders.

Who is sponsoring NCT04217421?

NCT04217421 is sponsored by dr. M.J.N.L. Benders.

What drugs are being tested in NCT04217421?

Interventions in NCT04217421: Allopurinol, Mannitol.

What condition does NCT04217421 study?

NCT04217421 studies Congenital Heart Disease in Children, Neuroprotection.

Is NCT04217421 still recruiting?

NCT04217421 is currently recruiting now. Last updated 16 May 2024.

Last reviewed 2024-05-16 · How we verify

NCT04217421: CRUCIAL

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Recruiting now Phase 3 Last updated 16 May 2024

What this trial tests

Phase 3 trial testing Allopurinol in Congenital Heart Disease in Children in 236 participants. Currently enrolling.

Timeline

14 February 2020

Primary endpoint
31 October 2026

31 December 2028

Quick facts

Lead sponsor	dr. M.J.N.L. Benders
Phase	Phase 3
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	236
Start date	14 February 2020
Primary completion	31 October 2026
Estimated completion	31 December 2028
Sites	4 locations across Netherlands

Drugs / interventions tested

Allopurinol (ALLOPURINOL) — full drug profile →
Mannitol (Mannitol) — full drug profile →

Conditions studied

Congenital Heart Disease in Children — all drugs for Congenital Heart Disease in Children →
Neuroprotection — all drugs for Neuroprotection →

Sponsor

dr. M.J.N.L. Benders

Who can join

Under 1 Month, any sex, with Congenital Heart Disease in Children or Neuroprotection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other trials of Allopurinol

Trials testing the same drug.

NCT07089888 — A Study of Dotinurad Versus Allopurinol in Tophaceous Gout · Phase 3 · recruiting
NCT07089875 — A Study of Dotinurad Versus Allopurinol in Participants With Gout · Phase 3 · recruiting
NCT05888233 — Allopurinol Improves Heart Function in African Americans With Resistant Hypertension · Phase 2 · recruiting
NCT06276556 — Extension Study of ABP-671 in Participants With Gout · Phase 2, PHASE3 · terminated
NCT04875702 — Treat-to-Target Serum Urate Versus Treat-to-Avoid Symptoms in Gout · Phase 4 · recruiting

Other recruiting trials for Congenital Heart Disease in Children

Currently open trials in the same condition.

NCT07029230 — Blood Based Assessment of sST2, Taken During and After Surgery, for Pediatric Patients With Heart Defects to Predict Hea · recruiting
NCT07414251 — Evaluation of Preoperative Preparation in Children Undergoing Cardiac Surgery or Catheterization · recruiting
NCT06383546 — Artificial Intelligence-enabled ECG Detection of Congenital Heart Disease in Children: a Novel Diagnostic Tool · recruiting
NCT05647161 — BAX602 in Preventing the Adhesion Around Great Cardiac Vessels in Pediatric Patients With Congenital Heart Disease Under · NA · active not recruiting
NCT05268094 — Comparison of Methods of Pulmonary Blood Flow Augmentation in Neonates: Shunt Versus Stent (The COMPASS Trial) · NA · active not recruiting

Other dr. M.J.N.L. Benders trials

Trials by the same sponsor.

NCT07189494 — European Newborn Study: Early Markers for a Better LifE · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04217421 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by dr. M.J.N.L. Benders
Last refreshed: 16 May 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04217421.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing