Duroplasty for injured cervical spinal cord with uncontrolled swelling: protocol of the DISCUS randomized controlled trial.

Autor: Saadoun S; Academic Neurosurgery, Molecular and Clinical Sciences, St. George's, University of London, London, UK. ssaadoun@sgul.ac.uk., Grassner L; Department of Neurosurgery, Christian Doppler Clinic, Paracelsus Medical University, Salzburg, Austria.; Institute of Molecular Regenerative Medicine, Spinal Cord Injury and Tissue Regeneration Center Salzburg, Paracelsus Medical University, Salzburg, Austria., Belci M; National Spinal Injury Centre, Stoke Mandeville Hospital, Buckinghamshire Healthcare NHS Trust, Aylesbury, Bucks, UK., Cook J; Oxford Clinical Trials Research Unit, Botnar Research Centre, University of Oxford, Oxford, UK., Knight R; Liverpool Clinical Trials Centre, University of Liverpool, Liverpool, UK., Davies L; Surgical Intervention Trials Unit, University of Oxford, Oxford, UK., Asif H; Academic Neurosurgery, Molecular and Clinical Sciences, St. George's, University of London, London, UK., Visagan R; Academic Neurosurgery, Molecular and Clinical Sciences, St. George's, University of London, London, UK., Gallagher MJ; Academic Neurosurgery, Molecular and Clinical Sciences, St. George's, University of London, London, UK., Thomé C; Department of Neurosurgery, Innsbruck Medical University, Innsbruck, Austria., Hutchinson PJ; Academic Neurosurgery, University of Cambridge, Cambridge, UK., Zoumprouli A; Neuro-Intensive Care Unit, Atkinson Morley Wing, St. George's Hospital NHS Foundation Trust, London, UK., Wade J; Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK., Farrar N; Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK., Papadopoulos MC; Academic Neurosurgery, Molecular and Clinical Sciences, St. George's, University of London, London, UK.; Neurosurgery, Atkinson Morley Wing, St. George's Hospital NHS Foundation Trust, London, UK.
Jazyk: angličtina
Zdroj: Trials [Trials] 2023 Aug 07; Vol. 24 (1), pp. 497. Date of Electronic Publication: 2023 Aug 07.
DOI: 10.1186/s13063-023-07454-2
Abstrakt: Background: Cervical traumatic spinal cord injury is a devastating condition. Current management (bony decompression) may be inadequate as after acute severe TSCI, the swollen spinal cord may become compressed against the surrounding tough membrane, the dura. DISCUS will test the hypothesis that, after acute, severe traumatic cervical spinal cord injury, the addition of dural decompression to bony decompression improves muscle strength in the limbs at 6 months, compared with bony decompression alone.
Methods: This is a prospective, phase III, multicenter, randomized controlled superiority trial. We aim to recruit 222 adults with acute, severe, traumatic cervical spinal cord injury with an American Spinal Injury Association Impairment Scale grade A, B, or C who will be randomized 1:1 to undergo bony decompression alone or bony decompression with duroplasty. Patients and outcome assessors are blinded to study arm. The primary outcome is change in the motor score at 6 months vs. admission; secondary outcomes assess function (grasp, walking, urinary + anal sphincters), quality of life, complications, need for further surgery, and mortality, at 6 months and 12 months from randomization. A subgroup of at least 50 patients (25/arm) also has observational monitoring from the injury site using a pressure probe (intraspinal pressure, spinal cord perfusion pressure) and/or microdialysis catheter (cord metabolism: tissue glucose, lactate, pyruvate, lactate to pyruvate ratio, glutamate, glycerol; cord inflammation: tissue chemokines/cytokines). Patients are recruited from the UK and internationally, with UK recruitment supported by an integrated QuinteT recruitment intervention to optimize recruitment and informed consent processes. Estimated study duration is 72 months (6 months set-up, 48 months recruitment, 12 months to complete follow-up, 6 months data analysis and reporting results).
Discussion: We anticipate that the addition of duroplasty to standard of care will improve muscle strength; this has benefits for patients and carers, as well as substantial gains for health services and society including economic implications. If the addition of duroplasty to standard treatment is beneficial, it is anticipated that duroplasty will become standard of care.
Trial Registration: IRAS: 292031 (England, Wales, Northern Ireland) - Registration date: 24 May 2021, 296518 (Scotland), ISRCTN: 25573423 (Registration date: 2 June 2021); ClinicalTrials.gov number : NCT04936620 (Registration date: 21 June 2021); NIHR CRN 48627 (Registration date: 24 May 2021).
(© 2023. BioMed Central Ltd., part of Springer Nature.)
Databáze: MEDLINE
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