The DISCUS Trial
Duroplasty for Injured cervical Spinal Cord with Uncontrolled Swelling
Specialty: Spinal Cord Injury, Neurosurgery
Status: Open to Recruitment
DISCUS is an emergency randomised controlled trial designed to compare two different types of surgery for Traumatic Spinal Cord Injury (TSCI) – surgery including laminectomy and duroplasty versus surgery including laminectomy.
Acute TSCI is a devastating condition that causes permanent disability (paralysis, numbness) and other complications such as chest and urine infections, pressure ulcers and loss of bladder and bowel control. In UK, one person suffers a spinal cord injury every 8 hours and there are about 40,000 people living with long-term disabilities from cord injuries.
After the injury, the spinal cord swells and the pressure inside the cord rises, which obstructs the flow of blood to the injury site, causing further damage. Surgery aims to straighten and fix the spine with screws and rods to reduce pressure on the injured cord. Based on our research, we think that the tough membrane around the spinal cord (dura) is a major, but unappreciated, cause of cord pressure after injury.
We have shown in a small study of patients that performing dural decompression (duroplasty) safely and effectively reduces pressure on the injured cord. We predict that patients who had standard treatment plus duroplasty will have better outcomes than those who had standard treatment alone. A similar operation is routinely used to decompress the swollen brain after brain injury, but, for spinal cord injury, standard treatment is surgery on the spine without duroplasty.
DISCUS is a Phase III, multicentre, international randomised controlled trial (RCT) which will investigate whether duroplasty helps improve patient outcomes after spinal cord injury.
Eligible patients will be randomised into one of two arms and followed up for 12 months after surgery. Assessments will include those which are offered as part of standard care, and some additional questionnaires looking at health-related quality of life.
We aim to recruit 222 patients aged 16 or older, with severe cervical spinal cord injuries. The local surgeons will have to assess whether the patient requires and is suitable for this kind of surgery, which will be done as soon as possible (within 72 hours of injury). Consent will need to be obtained from patients, or their family.
DISCUS includes an optional study for at least 50 patients who take part in the main trial. The aim of the mechanistic study is to determine how duroplasty improves outcome, i.e. whether duroplasty reduces cord compression, improves blood flow to the injured cord perfusion, improves cord metabolism and reduces cord inflammation.
We currently have 15 Major Trauma Centres (MTC) and seven Rehab sites open in UK.
|St George’s Hospital, London
|London Spinal Cord Injury Centre, London
|King's College Hospital, London
|Queen Elizabeth National Spinal Injuries Unit, Glasgow
|St Mary's Hospital, London
|National Spinal Injuries Centre, Stoke Mandeville
|Leeds General Infirmary, Leeds
|Yorkshire Regional Spinal Injuries Centre, Pinderfields
Queen Elizabeth University Hospital, Glasgow
|Midlands Centre for Spinal Injuries, RJAH, Birmingham
|The Royal London Hospital, London
|Princess Royal Spinal Cord Injuries Centre, Sheffield
|Aberdeen Royal Infirmary, Aberdeen
|North West Regional Spinal Injuries Centre, Southport
|Hull Royal Infirmary, Hull
|Salford Royal Hospital, Salford
|Addenbrookes Hospital, Cambridge
|Sheffield Teaching Hospitals, Sheffield
|The Walton Centre, Liverpool
|Queen Elizabeth Hospital, Birmingham
|Queen’s Medical Centre, Nottingham
|Royal Infirmary of Edinburgh, Edinburgh
We also have four international sites open so far and we anticipate more will join very soon.
|Shaare Zedek Medical Centre, Jerusalem
|Aarhus University Hospital, Denmark
|University Hospital Salzburg, Austria
|Skanes University Hospital Lund, Sweden
|UZ Leuven, Belgium
|Kepler University Hospital Linz, Austria
Funding and sponsor
DISCUS is funded by the National Institute of Health and Care Research (NIHR)’s Efficacy and Mechanism Evaluation (EME) programme and sponsored by St George’s University of London in UK. The international funder for DISCUS is Wings for Life charity.
Dr Matthew Gallagher, Dr Ayokunle Ogungbemi, Mr Stephen Dowd, Dr Dimitrios Sampanis, Dr Maurizio Belci, Dr Julia Wade, Dr Argyro Zoumprouli, Ms Lucy Davies
We are taking part in the NIHR Associate PI scheme.