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dc.contributor.authorCapion, Tenna
dc.contributor.authorLilja-Cyron, Alexander
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.authorSchack, Anders Emil
dc.contributor.authorRavlo, Celina
dc.contributor.authorIsaksen, Jørgen Gjernes
dc.contributor.authorLindschou, Jane
dc.contributor.authorGluud, Christian
dc.contributor.authorMathiesen, Tiit
dc.contributor.authorOlsen, Markus Harboe
dc.date.accessioned2024-11-11T09:32:08Z
dc.date.available2024-11-11T09:32:08Z
dc.date.issued2024-07-15
dc.description.abstractBackground - Insertion of an external ventricular drain (EVD) is a first-line treatment of acute hydrocephalus caused by aneurysmal subarachnoid haemorrhage (aSAH). Once the patient is clinically stable, the EVD is either removed or replaced by a permanent internal shunt. The optimal strategy for cessation of the EVD is unknown. Prompt closure carries a risk of acute hydrocephalus or redundant shunt implantations, whereas gradual weaning may increase the risk of EVD-related infections.<p> <p>Methods - DRAIN (Danish RAndomised Trial of External Ventricular Drainage Cessation IN Aneurysmal Subarachnoid Haemorrhage) is an international multicentre randomised clinical trial comparing prompt closure versus gradual weaning of the EVD after aSAH. The primary outcome is a composite of VP-shunt implantation, all-cause mortality, or EVD-related infection. Secondary outcomes are serious adverse events excluding mortality and health-related quality of life (EQ-5D-5L). Exploratory outcomes are modified Rankin Scale, Fatigue Severity Scale, Glasgow Outcome Scale Extended, and length of stay in the neurointensive care unit and hospital. 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%, alpha 5%, power 80%), 122 participants are required in each intervention group. Outcome assessment for the primary outcome, statistical analyses, and conclusion drawing will be blinded. Two independent statistical analyses and reports will be tracked using a version control system, and both will be published. Based on the final statistical report, the blinded steering group will formulate two abstracts.<p> <p>Conclusion - We present a pre-defined statistical analysis plan for the randomised DRAIN trial, which limits bias, p-hacking, and data-driven interpretations. This statistical analysis plan is accompanied by tables with simulated data, which increases transparency and reproducibility.en_US
dc.identifier.citationCapion, Lilja-Cyron, Juhler, Moeller, Sorteberg, Rønning, Poulsen, Wismann, Schack, Ravlo, Isaksen, Lindschou, Gluud, Mathiesen, Olsen. Prompt closure versus gradual weaning of external ventricular drain for hydrocephalus following aneurysmal subarachnoid haemorrhage: a statistical analysis plan for the DRAIN randomised clinical trial. Trials. 2024;25(1)en_US
dc.identifier.cristinIDFRIDAID 2292217
dc.identifier.doi10.1186/s13063-024-08305-4
dc.identifier.issn1745-6215
dc.identifier.urihttps://hdl.handle.net/10037/35616
dc.language.isoengen_US
dc.publisherSpringer Natureen_US
dc.relation.journalTrials
dc.rights.accessRightsopenAccessen_US
dc.rights.holderCopyright 2024 The Author(s)en_US
dc.rights.urihttps://creativecommons.org/licenses/by/4.0en_US
dc.rightsAttribution 4.0 International (CC BY 4.0)en_US
dc.titlePrompt closure versus gradual weaning of external ventricular drain for hydrocephalus following aneurysmal subarachnoid haemorrhage: a statistical analysis plan 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 4.0 International (CC BY 4.0)
Except where otherwise noted, this item's license is described as Attribution 4.0 International (CC BY 4.0)