Treatment with 5-AminoLEvuliNic acid before cardiac surgery (TALEN)
Research type
Research Study
Full title
Pre-operative 5-Aminolevulinic acid to activate haem oxygenase to improve outcomes in cardiac surgery: A dose finding study
IRAS ID
280513
Contact name
Arash Yavari
Contact email
Sponsor organisation
University of Oxford / Clinical Trials and Research Governance
Eudract number
2020-001135-27
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
This study is looking to find the best dose of a drug called 5-ALA given with iron given before coronary artery bypass graft (CABG) surgery to see whether it can protect the heart and vital organs from the stress of cardiac surgery.
CABG surgery is used to improve the flow of blood to the heart muscle. During the operation, blood flow to the heart is interrupted for a period of time while on a heart-lung machine. This allows the surgeon to operate on the heart but carries a risk of damage to the heart and other organs, such as the brain and kidneys. This study looks at a new way to protect the heart and other organs from this potential damage by preparing it for CABG surgery through harnessing a natural defence mechanism.
5-ALA is the short name for 5-aminolevulinic acid. 5-ALA is an amino acid (a building block of proteins) that is naturally present in food and drink such as red wine, Asian ginseng, green tea and vinegar. 5-ALA is also made naturally by the body and used to produce haemoglobin needed to make red blood cells. 5-ALA switches on a protein found in the body called HO-1 (haem oxygenase-1). HO-1 is a key cellular defence protein that is rapidly activated in response to stress and injury to protect cells. By giving ALA for a few days before surgery, this study aims to prime the HO-1 system to boost its ability to protect the heart and other organs during the operation. Specifically, the study will test different doses of 5-ALA to find the most effective and safe dose to activate HO-1.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
20/SC/0272
Date of REC Opinion
11 Sep 2020
REC opinion
Further Information Favourable Opinion