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dc.contributor.authorCapion, Tenna
dc.contributor.authorLilja-Cyron, Alexander
dc.contributor.authorOlsen, Markus Harboe
dc.contributor.authorJuhler, Marianne
dc.contributor.authorMoeller, Kirsten
dc.contributor.authorSorteberg, Angelika
dc.contributor.authorRønning, Pål Andre
dc.contributor.authorPoulsen, Frantz Rom
dc.contributor.authorWismann, Joakim
dc.contributor.authorRavlo, Celina
dc.contributor.authorIsaksen, Jørgen Gjernes
dc.contributor.authorLindschou, Jane
dc.contributor.authorGluud, Christian
dc.contributor.authorMathiesen, Tiit
dc.date.accessioned2023-08-25T11:11:43Z
dc.date.available2023-08-25T11:11:43Z
dc.date.issued2023-05-10
dc.description.abstractBackground: Aneurysmal subarachnoid haemorrhage (aSAH) is a life-threatening disease caused by rupture of an intracranial aneurysm. A common complication following aSAH is hydrocephalus, for which placement of an external ventricular drain (EVD) is an important first-line treatment. Once the patient is clinically stable, the EVD is either removed or replaced by a ventriculoperitoneal shunt. The optimal strategy for cessation of EVD treatment is, however, unknown. Gradual weaning may increase the risk of EVD-related infection, whereas prompt closure carries a risk of acute hydrocephalus and redundant shunt implantations. We designed a randomised clinical trial comparing the two commonly used strategies for cessation of EVD treatment in patients with aSAH.<p> <p>Methods: DRAIN is an international multi-centre randomised clinical trial with a parallel group design comparing gradual weaning versus prompt closure of EVD treatment in patients with aSAH. Participants are randomised to either gradual weaning which comprises a multi-step increase of resistance over days, or prompt closure of the EVD. The primary outcome is a composite outcome of VP-shunt implantation, all-cause mortality, or ventriculostomy-related infection. Secondary outcomes are serious adverse events excluding mortality, functional outcome (modified Rankin scale), health-related quality of life (EQ-5D) and Fatigue Severity Scale (FSS). Outcome assessment will be performed 6 months after ictus. Based on the sample size calculation (event proportion 80% in the gradual weaning group, relative risk reduction 20%, type I error 5%, power 80%), 122 patients are needed in each intervention group. Outcome assessment for the primary outcome, statistical analyses and conclusion drawing will be blinded.en_US
dc.identifier.citationCapion, Lilja-Cyron, Olsen, Juhler, Moeller, Sorteberg, Rønning, Poulsen, Wismann, Ravlo, Isaksen, Lindschou, Gluud, Mathiesen. Prompt closure versus gradual weaning of external ventricular drainage for hydrocephalus following aneurysmal subarachnoid haemorrhage: Protocol for the DRAIN randomised clinical trial. Acta Anaesthesiologica Scandinavica. 2023en_US
dc.identifier.cristinIDFRIDAID 2153262
dc.identifier.doi10.1111/aas.14263
dc.identifier.issn0001-5172
dc.identifier.issn1399-6576
dc.identifier.urihttps://hdl.handle.net/10037/30433
dc.language.isoengen_US
dc.publisherWileyen_US
dc.relation.journalActa Anaesthesiologica Scandinavica
dc.rights.accessRightsopenAccessen_US
dc.rights.holderCopyright 2023 The Author(s)en_US
dc.rights.urihttps://creativecommons.org/licenses/by-nc-nd/4.0en_US
dc.rightsAttribution-NonCommercial-NoDerivatives 4.0 International (CC BY-NC-ND 4.0)en_US
dc.titlePrompt closure versus gradual weaning of external ventricular drainage for hydrocephalus following aneurysmal subarachnoid haemorrhage: Protocol for the DRAIN randomised clinical trialen_US
dc.type.versionpublishedVersionen_US
dc.typeJournal articleen_US
dc.typeTidsskriftartikkelen_US
dc.typePeer revieweden_US


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Attribution-NonCommercial-NoDerivatives 4.0 International (CC BY-NC-ND 4.0)
Med mindre det står noe annet, er denne innførselens lisens beskrevet som Attribution-NonCommercial-NoDerivatives 4.0 International (CC BY-NC-ND 4.0)