The Renoprotective value of Leukodepletion in Heart Valve surgery: an external feasibility randomised controlled trial
Sponsor: University Hospitals Bristol
People who have surgery to repair damaged heart valves can suffer damage to their kidneys after their operation. This damage is caused by the heart-lung bypass machine, which takes over the job of pumping blood around the body whilst the heart is being operated on. The white blood cells (leukocytes) circulating in the blood react to the materials in the heart-lung bypass machine, which ‘activates’ them and causes inflammation throughout the body. This inflammation can damage the kidneys.
The ROLO study is looking to see if removing the ‘activated’ white blood cells from the blood (through a special filter in the heart-lung bypass machine) during surgery will reduce damage to the kidneys. Patients undergoing heart valve operations were allocated by chance to having their blood filtered using either a standard filter, which doesn’t filter out the white blood cells, or a new filter, which filters the blood in the same way as the standard filter, but also filters out the white blood cells.
Participants were followed-up for three months after surgery to see if they developed kidney injury.
Participants were recruited from Blackpool Teaching Hospitals NHS Foundation Trust. CTEU Bristol has been contracted to provide trial and data management services for the study, including the statistical analyses.
The study is now closed and the final report has been submitted to the funder.
Department of Health Disclaimer: The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the RfPB, NIHR, NHS or the Department of Health.