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Prompt closure versus gradual weaning of external ventricular drainage for hydrocephalus following aneurysmal subarachnoid haemorrhage: Protocol for the DRAIN randomised clinical trial |
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| Authors: | Tenna Capion Alexander Lilja-Cyron Markus Harboe Olsen Marianne Juhler Kirsten Møller Angelika Sorteberg Pål André Rønning Frantz Rom Poulsen Joakim Wismann Celina Ravlo Jørgen Isaksen Jane Lindschou Christian Gluud Tiit Mathiesen |
| Affiliation: | 1. Department of Neurosurgery, The Neuroscience Centre, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark;2. Copenhagen Trial Unit, Centre for Clinical Intervention Research, The Capital Region, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark Department of Neuroanaesthesiology, The Neuroscience Centre, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark;3. Department of Neurosurgery, The Neuroscience Centre, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark;4. Department of Neuroanaesthesiology, The Neuroscience Centre, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark;5. Department of Neurosurgery, Oslo University Hospital, Oslo, Norway;6. Department of Neurosurgery, Odense University Hospital, Odense, Denmark BRIDGE (Brain Research—Inter Disciplinary Guided Excellence), University of Southern Denmark, Odense, Denmark;7. 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;8. Copenhagen Trial Unit, Centre for Clinical Intervention Research, The Capital Region, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark;9. 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 |
| Abstract: | BackgroundAneurysmal 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.MethodsDRAIN 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.Trial RegistrationClinicalTrials.gov identifier: NCT03948256. |
| Keywords: | aneurysm aneurysmal subarachnoid haemorrhage external ventricular drain hydrocephalus protocol randomised clinical trial weaning |