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.
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
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
Parallel
Direct clamping of external ventricular drain
Procedure/SurgeryDaily 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.
Progressive (gradual) weaning of external ventricular drain
GeneticWhen 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.
Number of external ventricular drain-free days alive at Day 28
Number of days alive without an external ventricular drain within the 28 days following inclusion. If the patient had several external ventricular drain, the day of removal of the last external ventricular drain is used; if a permanent cerebrospinal fluid shunt (ventriculoperitoneal or ventriculoatrial) is placed, the day of permanent shunt placement is used. Patients who die before external ventricular drain removal are assigned 0 external ventricular drain-free days.
Proportion of patients with external ventricular drain-related infection
Proportion of patients meeting the Centers for Disease Control and Prevention criteria for meningitis or ventriculitis.
Proportion of patients with weaning failure
Weaning failure is defined as the occurrence of any of the following during a clamping trial or within 72 hours after external ventricular drain removal: neurological deterioration (loss of ≥2 Glasgow Coma Scale points, new neurological deficit, or uncontrollable headache), intracranial hypertension (ICP \>20 mmHg for more than 15 minutes), significant cerebrospinal fluid leak at the external ventricular drain insertion site, increase in ventricular size on control CT scan, or need to reinsert an external ventricular drain within 72 hours after removal.
Proportion of patients requiring permanent cerebrospinal fluid shunt (internalization)
Proportion of patients in whom a ventriculoperitoneal or ventriculoatrial shunt is placed.
Length of stay in critical care unit
Number of days from admission to critical care to discharge from critical care.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
