Show simple item record

dc.contributor.authorEdlmann, Ellieen
dc.contributor.authorThelin, Ericen
dc.contributor.authorCaldwell, Karenen
dc.contributor.authorTurner, Caroleen
dc.contributor.authorWhitfield, Peteren
dc.contributor.authorBulters, Diederiken
dc.contributor.authorHolton, Patricken
dc.contributor.authorSuttner, Nigelen
dc.contributor.authorOwusu-Agyemang, Kevinen
dc.contributor.authorAl-Tamimi, Yahia Zen
dc.contributor.authorGatt, Danielen
dc.contributor.authorThomson, Simonen
dc.contributor.authorAnderson, Ian Aen
dc.contributor.authorRichards, Oliveren
dc.contributor.authorGherle, Monicaen
dc.contributor.authorToman, Emmaen
dc.contributor.authorNandi, Dipankaren
dc.contributor.authorKane, Phillipen
dc.contributor.authorPantaleo, Beatriceen
dc.contributor.authorDavis-Wilkie, Carolen
dc.contributor.authorTarantino, Silviaen
dc.contributor.authorBarton, Garryen
dc.contributor.authorMarcus, Hani Jen
dc.contributor.authorChari, Aswinen
dc.contributor.authorBelli, Antonioen
dc.contributor.authorBond, Simonen
dc.contributor.authorGafoor, Rafaelen
dc.contributor.authorDawson, Sarahen
dc.contributor.authorWhitehead, Lynneen
dc.contributor.authorBrennan, Paulen
dc.contributor.authorWilkinson, Ianen
dc.contributor.authorKolias, Angelosen
dc.contributor.authorHutchinson, Peteren
dc.contributor.authorDex-CSDH trial collaborative and BNTRC collaborative.,en
dc.date.accessioned2019-03-09T00:30:30Z
dc.date.available2019-03-09T00:30:30Z
dc.date.issued2019-04-10en
dc.identifier.issn2045-2322
dc.identifier.urihttps://www.repository.cam.ac.uk/handle/1810/290403
dc.description.abstractThe Dex-CSDH trial is a randomised, double-blind, placebo-controlled trial of dexamethasone for patients with a symptomatic chronic subdural haematoma. The trial commenced with an internal pilot, whose primary objective was to assess the feasibility of multi-centre recruitment. Primary outcome data collection and safety were also assessed, whilst maintaining blinding. We aimed to recruit 100 patients from United Kingdom Neurosurgical Units within 12 months. Trial participants were randomised to a 2-week course of dexamethasone or placebo in addition to receiving standard care (which could include surgery). The primary outcome measure of the trial is the modified Rankin Scale at 6 months. This pilot recruited ahead of target; 100 patients were recruited within nine months of commencement. 47% of screened patients consented to recruitment. The primary outcome measure was collected in 98% of patients. No safety concerns were raised by the independent data monitoring and ethics committee and only five patients were withdrawn from drug treatment. Pilot trial data can inform on the design and resource provision for substantive trials. This internal pilot was successful in determining recruitment feasibility. Excellent follow-up rates were achieved and exploratory outcome measures were added to increase the scientific value of the trial.
dc.description.sponsorshipNIHR HTA
dc.format.mediumElectronicen
dc.languageengen
dc.publisherNature Publishing Group
dc.rights
dc.rights.uri
dc.subjectDex-CSDH trial collaborative and BNTRC collaborative.en
dc.subjectHumansen
dc.subjectHematoma, Subdural, Chronicen
dc.subjectDexamethasoneen
dc.subjectTreatment Outcomeen
dc.subjectDrug Administration Scheduleen
dc.subjectPilot Projectsen
dc.subjectDouble-Blind Methoden
dc.subjectPlacebo Effecten
dc.subjectRandomized Controlled Trials as Topicen
dc.titleDex-CSDH randomised, placebo-controlled trial of dexamethasone for chronic subdural haematoma: report of the internal pilot phase.en
dc.typeArticle
prism.issueIdentifier1en
prism.publicationDate2019en
prism.publicationNameScientific reportsen
prism.startingPage5885
prism.volume9en
dc.identifier.doi10.17863/CAM.37633
dcterms.dateAccepted2019-03-01en
rioxxterms.versionofrecord10.1038/s41598-019-42087-zen
rioxxterms.versionAM
rioxxterms.licenseref.urihttp://www.rioxx.net/licenses/all-rights-reserveden
rioxxterms.licenseref.startdate2019-04-10en
dc.contributor.orcidEdlmann, Ellie [0000-0002-7253-9115]
dc.contributor.orcidThelin, Eric [0000-0002-2338-4364]
dc.contributor.orcidBulters, Diederik [0000-0001-9884-9050]
dc.contributor.orcidMarcus, Hani J [0000-0001-8000-392X]
dc.contributor.orcidChari, Aswin [0000-0003-0053-147X]
dc.contributor.orcidBond, Simon [0000-0003-2528-1040]
dc.contributor.orcidDawson, Sarah [0000-0001-7401-2192]
dc.contributor.orcidKolias, Angelos [0000-0003-3992-0587]
dc.contributor.orcidHutchinson, Peter [0000-0002-2796-1835]
dc.identifier.eissn2045-2322
rioxxterms.typeJournal Article/Reviewen
pubs.funder-project-idNIHR Evaluation, Trials and Studies Coordinating Centre (NETSCC) (HTA/13/15/02)
cam.orpheus.successMon Jun 08 08:21:05 BST 2020 - The item has an open VoR version.*
rioxxterms.freetoread.startdate2022-03-08


Files in this item

Thumbnail
Thumbnail

This item appears in the following Collection(s)

Show simple item record