Strategies for Weaning From External Ventricular Drainage

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.

Conditions

• Subarachnoid Hemorrhage
• Hydrocephalus
• Intracranial Hypertension
• External Ventricular Drainage

Interventions

PROCEDURE

Direct clamping of external ventricular drain

Daily screening from Day 4 of standardized weanability criteria (no intracranial hypertension for 24h, minimal sedation, external ventricular drainage output \<200 ml/24h with a 3-hour intracranial pressure tolerance test or \<160 ml/24h without test). When criteria are met, the external ventricular drain is directly clamped. The clamping period lasts 48 hours under continuous intracranial pressure monitoring, with a control CT scan performed before external ventricular drain removal. The external ventricular drain is removed in the absence of neurological deterioration, intracranial hypertension, cerebrospinal fluid leak, or ventricular enlargement.

GENETIC

Progressive (gradual) weaning of external ventricular drain

When the patient's clinical condition improves (neurological improvement for ≥48 hours, no intracranial hypertension), the external ventricular drain level is raised by 5 mmHg per day. If neurological deterioration or intracranial hypertension occurs, the external ventricular drain level is lowered to the previous one. When the external ventricular drain level reaches ≥20 mmHg and is tolerated for 24 hours, the external ventricular drain is clamped for 48 hours under continuous intracranial pressure monitoring, with a control CT scan performed before external ventricular drain removal. Theexternal ventricular drain is removed in the absence of neurological deterioration, intracranial hypertension, cerebrospinal fluid leak, or ventricular enlargement.

Sponsors & Collaborators

• University Hospital, Angers

  lead OTHER_GOV

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-07-01

Primary Completion

2030-07-01

Completion

2031-10-01

Countries

• France

Study Locations