EUCTR2020-001135-27-GB进行中（未招募）1 期
Pre-operative 5-Aminolevulinic acid to activate haem oxygenase to improve outcomes in cardiac surgery: A dose finding study - Treatment with 5-AminoLEvuliNic acid before cardiac surgery (TALEN)
niversity of Oxford / Clinical Trials and Research Governance0 个研究点目标入组 55 人开始时间: 2020年7月17日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 55
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Age > 18 years
- •Scheduled for primary, isolated elective (non-emergent) CABG under cardiopulmonary bypass
- •Signed informed consent
- •Able and willing to comply with all study requirements
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
排除标准
- •Female participants who are pregnant, or breast feeding, or either unable or unwilling to use highly effective contraception if of child-bearing potential (under 55 years)
- •Acute or chronic types of porphyria
- •Known genetic haemochromatosis or clinically significant iron overload
- •History of clinically significant photosensitization
- •Current long-term (> 3 months) use of amiodarone
- •Concomitant use of hypericin extract (including St John’s Wort) or concomitant therapeutic dose oral iron replacement
- •History of allergic or adverse reaction to 5-ALA and/or SFC
- •Use of other investigational medical product(s) < 28 days prior to study
- •Intention to perform concomitant valve surgery (replacement and/or repair), emergency surgery (for catastrophic events) or redo surgery
- •Low cardiac output requiring catecholamine infusion and/or mechanical circulatory support prior to induction of anaesthesia for CABG
- •Recent acute myocardial infarction (within 3 weeks of surgery) – defined as elevated cardiac troponin > ULN together with symptoms of myocardial ischaemia and/or new ischaemic ECG changes within 2 weeks of surgery
- •Coronary surgery without cardiopulmonary bypass (i.e. off pump/OP-CABG) or induced fibrillating heart surgery
- •Inadequate renal or liver function defined as any of:
- •o estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73m2
- •o ALT and/or AST > 2.5 x ULN
- •o total bilirubin > 2 x ULN (unless documented Gilbert’s syndrome)
- •o known cirrhosis
- •o known active hepatitis infection
- •Any other condition which, in the opinion of the investigator, which makes the patient unsuitable for or may compromise their participation in the study, e.g. due to safety concerns or compliance with clinical study procedures
研究者
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