Strategies for Weaning From External Ventricular Drainage

Starting soon · Not applicable

Conditions studied: Subarachnoid Hemorrhage, Hydrocephalus, Intracranial Hypertension, External Ventricular Drainage

In brief

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.

Key facts

Study ID

NCT07630051

Run by

University Hospital, Angers

People needed

170

Starts

2026-07-01

Expected to finish

2031-10-01

Last updated by the study team

2026-06-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult patient (≥18 years)
• Admitted to critical care for non-traumatic subarachnoid hemorrhage for less than 3 days
• First external ventricular drain inserted within the last 3 days for hydrocephalus and/or intracranial hypertension
• Patient consent, or consent from a relative, or inclusion under emergency inclusion procedure
• Patient affiliated to or beneficiary of a social security scheme

You may not qualify if…

• Moribund patient or patient with established treatment limitation/withdrawal decisions
• Patient with a pre-existing ventriculoperitoneal or ventriculoatrial shunt
• Patient with chronic hydrocephalus
• Pregnant, lactating, or parturient woman
• Person deprived of liberty by judicial or administrative decision
• Person under involuntary psychiatric care
• Person under a legal protection measure
• Concurrent participation in another study involving external ventricular drainage management

Where it is running

• University Hospital Angers — Angers, France
• University Hospital Brest — Brest, France
• University Hospital Nantes — Nantes, France
• University Hospital Poitiers — Poitiers, France
• University Hospital Rennes — Rennes, France

Full record on ClinicalTrials.gov

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