PMID- 26009577 OWN - NLM STAT- MEDLINE DCOM- 20160128 LR - 20220317 IS - 2044-6055 (Electronic) IS - 2044-6055 (Linking) VI - 5 IP - 5 DP - 2015 May 25 TI - Protocol for a multicentre randomiSed controlled TRial of IntraVEnous immunoglobulin versus standard therapy for the treatment of transverse myelitis in adults and children (STRIVE). PG - e008312 LID - 10.1136/bmjopen-2015-008312 [doi] LID - e008312 AB - INTRODUCTION: Transverse myelitis (TM) is an immune-mediated disorder of the spinal cord which causes motor and sensory disturbance and limited recovery in 50% of patients. Standard treatment is steroids, and patients with more severe disease appear to respond to plasma exchange (PLEX). Intravenous immunoglobulin (IVIG) has also been used as an adjunct to steroids, but evidence is lacking. We propose the first randomised control trial in adults and children, to determine the benefit of additional treatment with IVIG. METHODS AND ANALYSIS: 170 adults and children aged over 1 year with acute first episode TM or neuromyelitis optica (with myelitis) will be recruited over a 2.5-year period and followed up for 12 months. Participants randomised to the control arm will receive standard therapy of intravenous methylprednisolone (IVMP). The intervention arm will receive the above standard therapy, plus additional IVIG. Primary outcome will be a 2-point improvement on the American Spinal Injury Association (ASIA) Impairment scale at 6 months postrandomisation by blinded assessors. Additional secondary and tertiary outcome measures will be collected: ASIA motor and sensory scales, Kurtzke expanded disability status scale, International Spinal Cord Injury (SCI) Bladder/Bowel Data Set, Client Services Receipt Index, Pediatric Quality of Life Inventory, EQ-5D, SCI Pain and SCI Quality of Life Data Sets. Biological samples will be biobanked for future studies. After 6-months' follow-up of the first 52 recruited patients futility analysis will be carried out. Health economics analysis will be performed to calculate cost-effectiveness. After 6 months' recruitment futility analysis will be performed. ETHICS AND DISSEMINATION: Research Ethics Committee Approval was obtained: 14/SC/1329. Current protocol: v3.0 (15/01/2015). Study findings will be published in peer-reviewed journals. TRIAL REGISTRATION NUMBERS: This study is registered with EudraCT (REF: 2014-002335-34), Clinicaltrials.gov (REF: NCT02398994) and ISRCTN (REF: 12127581). CI - Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions. FAU - Absoud, M AU - Absoud M AD - Department of Children's Neurosciences, Evelina Children's Hospital at Guy's and St Thomas' NHS Foundation Trust, King's Health Partners Academic Health Science Centre, London, UK. FAU - Gadian, J AU - Gadian J AD - Department of Children's Neurosciences, Evelina Children's Hospital at Guy's and St Thomas' NHS Foundation Trust, King's Health Partners Academic Health Science Centre, London, UK. FAU - Hellier, J AU - Hellier J AD - Department of Biostatistics, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK. FAU - Brex, P A AU - Brex PA AD - Department of Neurology, King's College Hospital NHS Foundation Trust, King's Health Partners Academic Health Science Centre, London, UK. FAU - Ciccarelli, O AU - Ciccarelli O AD - UCL Institute of Neurology, Queen Square, London, UK. FAU - Giovannoni, G AU - Giovannoni G AD - Centre for Neuroscience and Trauma, Blizard Institute, University of London and Bart's Health NHS Trust, London, UK. FAU - Kelly, J AU - Kelly J AD - King's Clinical Trials Unit, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK. FAU - McCrone, P AU - McCrone P AD - Centre for the Economics of Mental and Physical Health, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK. FAU - Murphy, C AU - Murphy C AD - King's Clinical Trials Unit, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK. FAU - Palace, J AU - Palace J AD - Department of Neurology, Oxford University Hospitals NHS Trust, Oxford, UK. FAU - Pickles, A AU - Pickles A AD - Department of Biostatistics, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK. FAU - Pike, M AU - Pike M AD - Department of Paediatric Neurology, Oxford University Hospitals NHS Trust, Oxford, UK. FAU - Robertson, N AU - Robertson N AD - Institute of Psychological Medicine and Clinical Neurosciences, Cardiff University and Cardiff and Vale NHS Trust, Cardiff, UK. FAU - Jacob, A AU - Jacob A AD - The Walton Centre, Walton Centre NHS Foundation Trust, Liverpool, UK. FAU - Lim, M AU - Lim M AD - Department of Children's Neurosciences, Evelina Children's Hospital at Guy's and St Thomas' NHS Foundation Trust, King's Health Partners Academic Health Science Centre, London, UK. LA - eng SI - EudraCT/2014-002335-34 SI - ISRCTN/ISRCTN12127581 SI - ClinicalTrials.gov/NCT02398994 GR - 11/129/148/DH_/Department of Health/United Kingdom GR - MR/L010305/1/MRC_/Medical Research Council/United Kingdom PT - Comparative Study PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20150525 PL - England TA - BMJ Open JT - BMJ open JID - 101552874 RN - 0 (Immunoglobulins, Intravenous) RN - X4W7ZR7023 (Methylprednisolone) SB - IM MH - Adult MH - Child MH - *Clinical Protocols MH - Cost-Benefit Analysis MH - Humans MH - Immunoglobulins, Intravenous/*therapeutic use MH - Methylprednisolone/therapeutic use MH - Myelitis, Transverse/*drug therapy MH - Quality of Life MH - Recovery of Function MH - Research Design MH - Spinal Cord/*pathology MH - Spinal Cord Injuries MH - *Standard of Care MH - Treatment Outcome PMC - PMC4452744 OTO - NOTNLM OT - HEALTH ECONOMICS OT - IMMUNOLOGY OT - NEUROLOGY OT - STATISTICS & RESEARCH METHODS EDAT- 2015/05/27 06:00 MHDA- 2016/01/29 06:00 PMCR- 2015/05/25 CRDT- 2015/05/27 06:00 PHST- 2015/05/27 06:00 [entrez] PHST- 2015/05/27 06:00 [pubmed] PHST- 2016/01/29 06:00 [medline] PHST- 2015/05/25 00:00 [pmc-release] AID - bmjopen-2015-008312 [pii] AID - 10.1136/bmjopen-2015-008312 [doi] PST - epublish SO - BMJ Open. 2015 May 25;5(5):e008312. doi: 10.1136/bmjopen-2015-008312.