NCT07630051Not yet recruiting
Strategies for Weaning From External Ventricular Drainage
Source: ClinicalTrials.gov · Last updated 5 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 170 (estimated)
- First submitted
- 1 Jun 2026
- Start date
- 1 Jul 2026
- Primary completion date
- 1 Jul 2030
- Lead sponsor
- University Hospital, Angers
- Diseases
- High blood pressure
- NCT number
- NCT07630051
What you commit to
- Study type: Interventional
- Planned participants: 170
- From 1 Jul 2026 to the primary completion date, 1 Jul 2030
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concurrent participation in another study involving external ventricular drainage management
Other illness
- Person under involuntary psychiatric care
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital Angers Coordinator of this site? Confirm its status | Angers | France | Unknown status |
| University Hospital Brest Coordinator of this site? Confirm its status | Brest | France | Unknown status |
| University Hospital Nantes Coordinator of this site? Confirm its status | Nantes | France | Unknown status |
| University Hospital Poitiers Coordinator of this site? Confirm its status | Poitiers | France | Unknown status |
| University Hospital Rennes Coordinator of this site? Confirm its status | Rennes | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.