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FältnamnIndikatorerMetadata
00004647naa a2201057 4500
001oai:prod.swepub.kib.ki.se:140656239
003SwePub
008240701s2019 | |||||||||||000 ||eng|
024a http://kipublications.ki.se/Default.aspx?queryparsed=id:1406562392 URI
024a https://doi.org/10.1038/s41598-019-42087-z2 DOI
040 a (SwePub)ki
041 a engb eng
042 9 SwePub
072 7a ref2 swepub-contenttype
072 7a art2 swepub-publicationtype
100a Edlmann, E4 aut
2451 0a Dex-CSDH randomised, placebo-controlled trial of dexamethasone for chronic subdural haematoma: report of the internal pilot phase
264 c 2019-04-10
264 1b Springer Science and Business Media LLC,c 2019
520 a The 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 No safety concerns were raised by the independent data monitoring and ethics committee and only five patients were withdrawn from drug treatment.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.
700a Thelin, EPu Karolinska Institutet4 aut
700a Caldwell, K4 aut
700a Turner, C4 aut
700a Whitfield, P4 aut
700a Bulters, D4 aut
700a Holton, P4 aut
700a Suttner, N4 aut
700a Owusu-Agyemang, K4 aut
700a Al-Tamimi, YZ4 aut
700a Gatt, D4 aut
700a Thomson, S4 aut
700a Anderson, IA4 aut
700a Richards, O4 aut
700a Gherle, M4 aut
700a Toman, E4 aut
700a Nandi, D4 aut
700a Kane, P4 aut
700a Pantaleo, B4 aut
700a Davis-Wilkie, C4 aut
700a Tarantino, S4 aut
700a Barton, G4 aut
700a Marcus, HJ4 aut
700a Chari, A4 aut
700a Belli, A4 aut
700a Bond, S4 aut
700a Gafoor, R4 aut
700a Dawson, S4 aut
700a Whitehead, L4 aut
700a Brennan, P4 aut
700a Wilkinson, I4 aut
700a Kolias, AG4 aut
700a Hutchinson, PJA4 aut
700a Badran, K4 aut
700a Coulter, I4 aut
700a Gallagher, MJ4 aut
700a Hogg, FRA4 aut
700a Pringle, C4 aut
700a Razak, A4 aut
700a Soleiman, H4 aut
700a Piper, R4 aut
700a Vintu, M4 aut
700a Wahba, A4 aut
700a Wiggins, A4 aut
700a Yakoub, KM4 aut
700a Zaben, M4 aut
700a Zolnourian, A4 aut
700a Bodkin, P4 aut
700a Cirstea, E4 aut
700a Critchley, G4 aut
700a Eglinton, C4 aut
700a Finlay, L4 aut
700a Georgieva, D4 aut
700a Gurusinghe, N4 aut
700a Haliasos, N4 aut
700a Holliman, D4 aut
700a Hossain-Ibrahim, K4 aut
700a Hussain, M4 aut
700a Kandasamy, J4 aut
700a Kambafwile, M4 aut
700a Nannapaneni, R4 aut
700a de Gordoa, LOR4 aut
700a Papadopoulos, MC4 aut
700a Paraskevopoulos, D4 aut
700a Patel, J4 aut
700a Prasad, KSM4 aut
700a Tzerakis, N4 aut
710a Karolinska Institutet4 org
773t Scientific reportsd : Springer Science and Business Media LLCg 9:1, s. 5885-q 9:1<5885-x 2045-2322
856u https://www.nature.com/articles/s41598-019-42087-z.pdf
8564 8u http://kipublications.ki.se/Default.aspx?queryparsed=id:140656239
8564 8u https://doi.org/10.1038/s41598-019-42087-z

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