Evidence map›Paper›PMID 26009577›Full record

Trial reportBMJ open2015

Protocol for a multicentre randomiSed controlled TRial of IntraVEnous immunoglobulin versus standard therapy for the treatment of transverse myelitis in adults and children (STRIVE).

M Absoud, J Gadian, J Hellier, P A Brex, O Ciccarelli, G Giovannoni, J Kelly, P McCrone, C Murphy, J Palace and 5 more

Registry-linked trialOpen access · goldAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMJ open, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02398994 (A Multicentre randomiSed Controlled TRial of IntraVEnous Immunoglobulin), which is not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
3.5field-weighted citation impact, top 7% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02398994 phase3terminatednot on this map

A Multicentre randomiSed Controlled TRial of IntraVEnous Immunoglobulin (IVIg) Versus Standard Therapy for the Treatment of Transverse Myelitis in Adults and Children

TypeinterventionalSponsorGuy's and St Thomas' NHS Foundation TrustRan2015 to 2016Enrolled2ConditionsMyelitis, Transverse, Neuromyelitis OpticaArmsIntravenous Methylprednisolone, Intravenous Immunoglobulin
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 20 citations in OpenAlex.

  1. Review
  2. Acute Transverse and Flaccid Myelitis in Children.Current treatment options in neurology · 2019
    Review
  3. Acute Transverse Myelitis in Children, Literature Review.Iranian journal of child neurology · 2018
    Review
  4. Review
  5. Article
  6. Article
  7. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors at 8 institutions in 2 countries.

M AbsoudDepartment 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.
J GadianDepartment 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.
J HellierDepartment of Biostatistics, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.
P A BrexDepartment of Neurology, King's College Hospital NHS Foundation Trust, King's Health Partners Academic Health Science Centre, London, UK.
O CiccarelliUCL Institute of Neurology, Queen Square, London, UK.
G GiovannoniCentre for Neuroscience and Trauma, Blizard Institute, University of London and Bart's Health NHS Trust, London, UK.
J KellyKing's Clinical Trials Unit, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.
P McCroneCentre for the Economics of Mental and Physical Health, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.
C MurphyKing's Clinical Trials Unit, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.
J PalaceDepartment of Neurology, Oxford University Hospitals NHS Trust, Oxford, UK.
A PicklesDepartment of Biostatistics, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.
M PikeDepartment of Paediatric Neurology, Oxford University Hospitals NHS Trust, Oxford, UK.
N RobertsonInstitute of Psychological Medicine and Clinical Neurosciences, Cardiff University and Cardiff and Vale NHS Trust, Cardiff, UK.
A JacobThe Walton Centre, Walton Centre NHS Foundation Trust, Liverpool, UK.
M LimDepartment 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.
King's College London · GBGuy's and St Thomas' NHS Foundation Trust · GBOxford University Hospitals NHS Trust · GBCardiff University · GBKing's College Hospital NHS Foundation Trust · GBUniversity College London · GBUniversity of London · GBWalton Centre · GB

Funding

Department of Health 11/129/148Medical Research Council MR/L010305/1
6 · The paper itself

Abstract

introductionTransverse 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).

Indexed as

Clinical ProtocolsStandard of CareAdultChildCost-Benefit AnalysisHumansImmunoglobulins, IntravenousMethylprednisoloneMyelitis, TransverseQuality of LifeRecovery of FunctionResearch DesignSpinal CordSpinal Cord InjuriesTreatment OutcomeImmunoglobulins, IntravenousMethylprednisoloneHEALTH ECONOMICSIMMUNOLOGYNEUROLOGYSTATISTICS & RESEARCH METHODS

Identifiers

PMID26009577
PMCPMC4452744
OpenAlexW2146306573

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.