Trial of 5-Aminolevulinic Acid to Enhance Cardioprotection (TALEN)
Research type
Research Study
Full title
A randomised control trial of 5-Aminolevulinic Acid in combination with Sodium Ferrous Citrate to Enhance Cardioprotection in Adults undergoing Cardiac Surgery
IRAS ID
203611
Contact name
Houman Ashrafian
Contact email
Sponsor organisation
University of Oxford
Eudract number
2015-001321-17
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
All surgery which uses a heart lung machine to allow the heart to be stopped during the operation causes a degree of damage to the heart. In many patients this results in a reduction of the amount of blood being pumped per minute by their heart when it is restarted. In turn this causes a poor supply of nutrients and oxygen to other organs, damaging them. Ultimately this decreases the chance of a patient leaving hospital alive, reduces life span of those who survive and their quality of life. This study aims to examine whether 5-Aminolevulinic acid, a common component of foods, when given in combination with sodium ferrous citrate (a source of dietary iron) can reduce the injury incurred to the heart during such surgery and thus increase the volume of blood pumped per minute following the operation. It will look at this issue in patients who undergo bypass grafts to vessels on their heart, replacement of a heart valve, or both simultaneously.
The trial will take place at John Radcliffe Hospital Oxford and Queen Elizabeth's Hospital Birmingham with the possibility of including further sites. The trial is funded through the University of Oxford by SBI Pharmaceuticals Japan.
Patients who consent to participate in the study will be randomized to receive: high dose study medication; low dose study medication; or matching placebo "dummy" medication. They will take these tablets for three days prior to their surgery. The patients surgery will be conducted as it would have been if they weren't part of the trial apart from additional observations will be recorded and additional blood and tissue samples will be taken and analysed.REC name
South Central - Oxford C Research Ethics Committee
REC reference
16/SC/0474
Date of REC Opinion
2 Dec 2016
REC opinion
Further Information Favourable Opinion