Strategies for Weaning From External Ventricular Drainage

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Angers

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Direct clamping of external ventricular drain
  • Progressive (gradual) weaning of external ventricular drain

Treatment groups

170 Participants
are divided into 2 treatment groups

Sponsors and collaborators