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.

Autor: Capion T; Department of Neurosurgery, The Neuroscience Centre, Copenhagen University Hospital ─ Rigshospitalet, Inge Lehmanns Vej 8, Copenhagen, 2100, Denmark. tenna.baek.capion@regionh.dk., Lilja-Cyron A; Department of Neurosurgery, The Neuroscience Centre, Copenhagen University Hospital ─ Rigshospitalet, Inge Lehmanns Vej 8, Copenhagen, 2100, Denmark., Juhler M; Department of Neurosurgery, The Neuroscience Centre, Copenhagen University Hospital ─ Rigshospitalet, Inge Lehmanns Vej 8, Copenhagen, 2100, Denmark.; Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark., Møller K; Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.; Department of Neuroanaesthesiology, The Neuroscience Centre, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark., Sorteberg A; Department of Neurosurgery, Oslo University Hospital, Oslo, Norway.; Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, Norway., Rønning PA; Department of Neurosurgery, Oslo University Hospital, Oslo, Norway., Poulsen FR; Department of Neurosurgery, Odense University Hospital, Odense, Denmark.; Clinical Institute and BRIDGE (Brain Research ─ Inter Disciplinary Guided Excellence), University of Southern Denmark, Odense, Denmark., Wismann J; Department of Neurosurgery, Odense University Hospital, Odense, Denmark.; Clinical Institute and BRIDGE (Brain Research ─ Inter Disciplinary Guided Excellence), University of Southern Denmark, Odense, Denmark., Schack AE; Department of Neurosurgery, Odense University Hospital, Odense, Denmark.; Clinical Institute and BRIDGE (Brain Research ─ Inter Disciplinary Guided Excellence), University of Southern Denmark, Odense, Denmark., Ravlo C; Department of Neurosurgery, Ophthalmology and Otorhinolaryngology, Division of Clinical Neurosciences, University Hospital of North Norway, Tromsø, Norway.; Department of Clinical Medicine, Faculty of Health Sciences, UiT The Arctic University of Norway, Tromsø, Norway., Isaksen J; Department of Neurosurgery, Ophthalmology and Otorhinolaryngology, Division of Clinical Neurosciences, University Hospital of North Norway, Tromsø, Norway.; Department of Clinical Medicine, Faculty of Health Sciences, UiT The Arctic University of Norway, Tromsø, Norway., Lindschou J; Copenhagen Trial Unit, Centre for Clinical Intervention Research, The Capital Region, Copenhagen University Hospital ─ Rigshospitalet, Copenhagen, Denmark., Gluud C; Copenhagen Trial Unit, Centre for Clinical Intervention Research, The Capital Region, Copenhagen University Hospital ─ Rigshospitalet, Copenhagen, Denmark.; Department of Regional Health Research, The Faculty of Health Sciences, University of Southern Denmark, Odense, Denmark., Mathiesen T; Department of Neurosurgery, The Neuroscience Centre, Copenhagen University Hospital ─ Rigshospitalet, Inge Lehmanns Vej 8, Copenhagen, 2100, Denmark.; Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark., Olsen MH; Department of Neuroanaesthesiology, The Neuroscience Centre, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.; Copenhagen Trial Unit, Centre for Clinical Intervention Research, The Capital Region, Copenhagen University Hospital ─ Rigshospitalet, Copenhagen, Denmark.
Jazyk: angličtina
Zdroj: Trials [Trials] 2024 Jul 15; Vol. 25 (1), pp. 479. Date of Electronic Publication: 2024 Jul 15.
DOI: 10.1186/s13063-024-08305-4
Abstrakt: Background: 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.
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.
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.
Trial Registration: ClinicalTrials.gov identifier: NCT03948256. Registered on May 13, 2019.
(© 2024. The Author(s).)
Databáze: MEDLINE
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