Strategies for Weaning From External Ventricular Drainage
SEVDVE2
2 other identifiers
interventional
170
1 country
5
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2026
Longer than P75 for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 1, 2026
CompletedFirst Posted
Study publicly available on registry
June 5, 2026
CompletedStudy Start
First participant enrolled
July 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2030
Study Completion
Last participant's last visit for all outcomes
October 1, 2031
June 5, 2026
June 1, 2026
4 years
June 1, 2026
June 1, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
28 days after inclusion
Secondary Outcomes (9)
Proportion of patients with external ventricular drain-related infection
From inclusion up to hospital discharge or Day 90 after inclusion, whichever comes first
Proportion of patients with weaning failure
From start of weaning until 72 hours after external ventricular drain removal
Proportion of patients requiring permanent cerebrospinal fluid shunt (internalization)
Up to Day 90 after inclusion
Length of stay in critical care unit
Up to Day 90 after inclusion
Length of hospital stay
Up to Day 90 after inclusion
- +4 more secondary outcomes
Study Arms (2)
Direct clamping
EXPERIMENTALFrom 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.
Progressive (gradual) weaning
ACTIVE COMPARATORWhen 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.
Interventions
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 external ventricular drain is removed in the absence of neurological deterioration, intracranial hypertension, cerebrospinal fluid leak, or ventricular enlargement.
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 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.
Eligibility Criteria
You may qualify if:
- 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 affiliated to or beneficiary of a social security scheme
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
University Hospital Angers
Angers, France
University Hospital Brest
Brest, France
University Hospital Nantes
Nantes, France
University Hospital Poitiers
Poitiers, France
University Hospital Rennes
Rennes, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Single-blind design (participant). Because the study evaluates two strategies for managing a medical device (external ventricular drain), it is not feasible to blind the care providers, investigators, or outcome assessors. However, participants are not informed of their randomized group and have no means to identify it during the study.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 1, 2026
First Posted
June 5, 2026
Study Start (Estimated)
July 1, 2026
Primary Completion (Estimated)
July 1, 2030
Study Completion (Estimated)
October 1, 2031
Last Updated
June 5, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- The data will be shared after signing a negotiated data transfer agreement ( data access agreement), for the duration specified in the agreement.
- Access Criteria
- The data will be made available via secure transfer (sharing platform approved by the university hospital: BlueFiles or Oodrive).
Data will be shared upon reasonable request. Only de-identified data will be shared. Any data collected during the study may be shared. The protocol will be shared initially. Other documents may be shared at a later date upon request (e.g., the CRF to allow a collaborator to select the data they wish to access). The recipients of the data will be researchers. The data will be available for any purpose deemed relevant by the study investigator, based on a protocol provided by the requester, after verification of the obtaining of regulatory approvals, including the favorable opinion of an ethics committee.