Strategies for Weaning From External Ventricular Drainage

Обзор

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.

Подробное описание

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%.

Вмешательства

• Процедура 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 extern
• Генная терапия 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 pres

Первичные конечные точки

• Number of external ventricular drain-free days alive at Day 28 [Срок оценки: 28 days after inclusion]

Вторичные конечные точки (9)

• Proportion of patients with external ventricular drain-related infection [Срок оценки: From inclusion up to hospital discharge or Day 90 after inclusion, whichever comes first]
• Proportion of patients with weaning failure [Срок оценки: From start of weaning until 72 hours after external ventricular drain removal]
• Proportion of patients requiring permanent cerebrospinal fluid shunt (internalization) [Срок оценки: Up to Day 90 after inclusion]
• Length of stay in critical care unit [Срок оценки: Up to Day 90 after inclusion]
• Length of hospital stay [Срок оценки: Up to Day 90 after inclusion]
• Modified Rankin Scale score at Day 90 [Срок оценки: Day 90 ± 7 days after inclusion]
• All-cause mortality at Day 28 [Срок оценки: Day 28 after inclusion]
• All-cause mortality at Day 90 [Срок оценки: Day 90 after inclusion]
• Number of days alive and at home at Day 90 [Срок оценки: Day 90 after inclusion]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Франция · 5 центров

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

Идентификаторы

NCT: NCT07630051 · 49RC25_0450 · 2026-A00901-50

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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