Clinical Trial

Strategies for Weaning From External Ventricular Drainage

Study acronym: SEVDVE2
Not Yet Recruiting
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Summary
External ventricular drainage is frequently used in neurocritical care, particularly in patients admitted for non-traumatic subarachnoid hemorrhage who develop hydrocephalus and/or intracranial hypertension. While external ventricular drainage is often initially lifesaving, its prolonged maintenance is associated with complications, especially infections and prolonged hospital length of stay. There is currently no consensus on the optimal weaning strategy. Two approaches are used in routine practice: direct clamping (the external ventricular drain is closed as soon as weanability criteria are met) and gradual weaning (the external ventricular drain level is progressively raised before final clamping). No randomized controlled trial has yet demonstrated the superiority of one strategy over the other in patients with non-traumatic subarachnoid hemorrhage. The investigators hypothesize that a direct clamping strategy, combined with daily screening of standardized weanability criteria, will reduce the duration of external ventricular drain maintenance compared with the conventional gradual weaning strategy. SEVDVE-2 is a multicenter, randomized, controlled, parallel-group, single-blind superiority trial that will compare these two weaning strategies in 170 adult patients admitted to critical care for non-traumatic subarachnoid hemorrhage with a first external ventricular drain inserted within the previous 3 days. Patients will be randomized 1:1, stratified on the presence of an intraventricular hematoma. The primary outcome is the number of external ventricular drain-free days alive at Day 28.
Trial Details
NCT Number NCT07630051
Lead Sponsor University Hospital, Angers
Conditions Subarachnoid Hemorrhage, Hydrocephalus, Intracranial Hypertension, External Ventricular Drainage
Enrollment 170 participants
Start Date 2026-07-01
Primary Completion 2030-07-01 (estimated)
Study Completion 2031-10-01 (estimated)
Updated on ClinicalTrials.gov 2026-06-05