NL-OMON52736招募中3 期
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 个研究点目标入组 236 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 236
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 至 1（—）
入选标准
- •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.
排除标准
- •- 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*.
研究者
相似试验
招募中
3 期
CeRebrUm and CardIac protection with ALlopurinol in Neonates with Critical Congenital Heart Disease requiring Cardiac Surgery with Cardiopulmonary Bypass2024-513041-37-00Universitair Medisch Centrum Utrecht236
进行中（未招募）
1 期
CeRebrUm and CardIac protection with ALlopurinol in Neonates with Critical Congenital Heart Disease requiring Cardiac Surgery with Cardiopulmonary BypassBrain injury in neonates with critical congenital heart disease requiring cardiac surgery with cardiopulmonary bypass.MedDRA version: 21.1Level: PTClassification code: 10067967Term: Brain injury Class: 100000004852MedDRA version: 20.0Level: LLTClassification code: 10010495Term: Congenital heart disease NOS Class: 10010331CTIS2024-513041-37-00niversitair Medisch Centrum Utrecht236
已完成
3 期
The effect of Allopurinol in prevention of contrast induced nephropathy in patients undergoing angioplastyephropathy.Disorder of kidney and ureter, unspecified28.9IRCT20190406043182N1Tabriz University of Medical Sciences100
进行中（未招募）
不适用
Allopurinol and cardiovascular outcomes in patients with ischaemic heart disease (ALL-HEART)Ischaemic Heart Disease (IHD), angina or myocardial infarctionMedDRA version: 16.0Level: LLTClassification code 10023024Term: Ischaemic heart diseaseSystem Organ Class: 100000004849EUCTR2013-003559-39-GBThe University of Dundee5,215
已完成
不适用
Allopurinol and cardiovascular outcomes in patients with ischaemic heart diseaseISRCTN32017426The University of Dundee (UK)5,937