Strategies for Weaning From External Ventricular Drainage

SEVDVE-2 is a multicenter, randomized, controlled, parallel-group, single-blind superiority trial conducted in French university hospital neurocritical care units (research involving routine-care interventions).

Background and rationale: External ventricular drainage is commonly used in patients with non-traumatic subarachnoid hemorrhage to manage hydrocephalus and/or intracranial hypertension. Prolonged external ventricular drain maintenance is associated with infectious and other complications and prolongs hospital stay. There is no recommendation on the optimal weaning strategy. A retrospective multicenter cohort (SEVDVE) by the investigators showed heterogeneous practices (61% gradual weaning, 39% direct clamping) and suggested that direct clamping shortens the external ventricular drain maintenance duration but is associated with more clamping failures. The investigators have developed standardized daily weanability criteria to better define the timing of the weaning attempt.

Intervention: Eligible adult patients hospitalized in critical care for non-traumatic subarachnoid hemorrhage with a first external ventricular drain in place for less than 3 days are randomized 1:1 (stratified on the presence of intraventricular hematoma) to one of two strategies:

• Direct clamping (experimental arm): from Day 4, daily screening of weanability criteria (no episode of intracranial hypertension for the previous 24 hours, minimal sedation, external ventricular drain 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 for 48 hours.
• Gradual weaning (control arm): when the patient improves (neurological improvement for at least 48 hours, no intracranial hypertension), the external ventricular drain level is raised by 5 mmHg per day. When the external ventricular drain level is ≥20 mmHg and tolerated for 24 hours, the external ventricular drain is clamped for 48 hours.

In both arms, the external ventricular drain is removed after 48 hours of clamping if no neurological deterioration, intracranial hypertension, cerebrospinal fluid leak, or ventricular enlargement occurs. If clamping fails, drainage is resumed and a new attempt is made under the same strategy, within the 28 days after the start of weaning. After Day 14, internalization (ventriculoperitoneal or ventriculoatrial shunt) is to be discussed after two clamping failures.

Patients are blinded to their randomization group. Care providers, investigators, and outcome assessors cannot be blinded because the procedure involves device handling.

Study visits: V1 inclusion visit, daily follow-up between V1 and V2, V2 at hospital discharge or Day 28 ± 3 days, V3 telephone interview at Day 90 ± 7 days. All collected data are those routinely recorded during standard care.

Sample size: 170 patients (85 per arm), based on an expected difference of 3 EVD-free days at Day 28 (13 vs 10), standard deviation 6 days, alpha 5%, power 90%.

Inclusion criteria

• 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

Exclusion criteria

• 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