Iron Status in patients undergoing Aortic Valve Replacement Surgery
Research type
Research Study
Full title
Associations of preoperative body iron status with patient outcomes following aortic valve replacement surgery
IRAS ID
230248
Contact name
Enoch Akowuah
Contact email
Sponsor organisation
South Tees Hospitals NHS FT
Duration of Study in the UK
0 years, 4 months, 2 days
Research summary
The MAVRIC trial recruited 270 patients requiring Aortic Valve Replacement (AVR) surgery (heart surgery to replace one of the heart valves), at one hospital. Patients were randomised to receive their AVR surgery via a conventional surgical incision, where the chest (sternum) is divided completely, or via a small incision where only part of the chest is divided to access the heart. Patients consented to the collection of blood samples as part of this trial, and also for future use.
This application seeks an ethical and governance opinion on the analysis of these blood samples for markers of iron levels and the link of this information with the original research data. This information will be linked by the unique study ID (an anonymous number assigned to each patient). Those analysing the samples and those re-analysing the trial data will not be able to identify individual patients. All data is psuedoanonymised.
REC name
East of Scotland Research Ethics Service REC 2
REC reference
17/ES/0151
Date of REC Opinion
17 Nov 2017
REC opinion
Favourable Opinion