Two Ways to Remove a Brain Fluid Drain After Bleeding Around the Brain
Compares closing the drain at once with gradual weaning in adults after subarachnoid hemorrhage.
Key facts
- Who runs it
- University Hospital, Angers
- Where
- Angers, Brest, Nantes, Poitiers, and Rennes, FranceSee the 5 sites
- Trial code
- Registry title
- Strategies for Weaning From External Ventricular Drainage
- Status
- Not yet recruiting
- People taking part
- 170 people, planned
- Started
- 1 Jul 2026
- Expected to end
- 1 Oct 2031
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Direct clamping of external ventricular drain
- Progressive (gradual) weaning of external ventricular drain
- Record updated
- 5 June 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults in intensive care with bleeding around the brain (not caused by injury) who have a drain placed in the last 3 days to relieve fluid or pressure. It compares two ways of stopping the drain.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Bleeding around the brain (subarachnoid hemorrhage) not caused by injury, in intensive care for less than 3 days. First external ventricular drain placed within the last 3 days for hydrocephalus and/or raised pressure in the head.
- Earlier treatment
- A first external ventricular drain must have been placed within the last 3 days.
Main reasons for not taking part
- Dying patients, or those with decisions to limit or stop treatment
- Existing ventriculoperitoneal or ventriculoatrial shunt
- Long-standing (chronic) hydrocephalus
- Pregnant, breastfeeding or just-delivered women
- Taking part in another study on external ventricular drain care
The registry criteria, word for word
Show all 13 criteriaShow less
Who can take part
- 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
Who cannot take part
- Concurrent participation in another study involving external ventricular drainage management
- Person under involuntary psychiatric care
- 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 a legal protection measure
Where in France
- University Hospital AngersAngers, FranceContact: Maeva CAMPFORT, MDNo longer taking part
- University Hospital BrestBrest, FranceContact: Olivier LANGERON, MD PhDNo longer taking part
- University Hospital NantesNantes, FranceContact: Antoine ROQUILLY, MD PhDNo longer taking part
- University Hospital PoitiersPoitiers, FranceContact: Claire DAHYOT-FIZELIER, MD PhDNo longer taking part
- University Hospital RennesRennes, FranceContact: Yoann LAUNEY, MD PhDNo longer taking part
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The 2 groups in the trial
- Direct clampingTreatment being tested
From Day 4 after external ventricular drain insertion, weanability criteria are screened daily: absence of intracranial hypertension for the previous 24 hours, minimal sedation, and external ventricular drainage output below predefined thresholds (\<200 ml/24h with a 3-hour intracranial pressure tolerance test confirming intracranial pressure does not rise by more than 5 mmHg at 3 hours; or \<160 ml/24h without test). When criteria are met, the external ventricular drain is directly clamped for 48 hours, under continuous ICP monitoring.
Treatment: Direct clamping of external ventricular drain
- Progressive (gradual) weaningExisting treatment, for comparison
When the patient's condition improves (neurological improvement for at least 48 hours, no intracranial hypertension), the external ventricular drain level is progressively raised by 5 mmHg per day, provided no neurological deterioration or intracranial hypertension occurs (otherwise 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.
Treatment: Progressive (gradual) weaning of external ventricular drain
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Strategies for Weaning From External Ventricular Drainage
- Plain-language title
- Two Ways to Remove a Brain Fluid Drain After Bleeding Around the BrainGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 5 June 2026