EUCTR2015-001321-17-GB进行中（未招募）1 期
A randomised control trial of 5-Aminolevulinic Acid in combination with Sodium Ferrous Citrate to Enhance Cardioprotection in Adults undergoing Cardiac Surgery - Trial of 5-Aminolevulinic Acid to Enhance Cardioprotection (TALEN)
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 402
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
- •Undergoing on-pump cardiac surgery. Procedure must be: Coronary artery by-pass grafting, Aortic valve replacement/repair or combination of both.
- •Participant is willing and able to give informed consent for participation in the trial.
- •Male or Female, aged 18 years or above.
- •In the Investigator’s opinion, is able and willing to comply with all trial requirements.
- •Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the trial.
- •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 75
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 325
排除标准
- •Female participant who is pregnant or lactating.
- •Porphyria or family history of porphyria
- •Haemochromatosis
- •Past history of photosensitization
- •Current use of photo-sensitising medications e.g. tetracyclines, sulfonamides, fluoroquinolones
- •Current use of Fluoroquinolones, hypericin extract or iron replacement therapy
- •Known sensitivity to 5-ALA or SFC
- •Involvement in another trial of an investigational medical product within the past month
- •Intention to perform other cardiac procedures and surgery for catastrophic events
- •Emergency cases where 3-days pre-treatment is not possible
研究者
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