Subarachnoid HemorrhageSEVDVE2NCT07630051
Strategies for Weaning From External Ventricular Drainage
A study testing Direct clamping of external ventricular drain and Progressive (gradual) weaning of external ventricular drain in people with Subarachnoid Hemorrhage and Hydrocephalus, run by University Hospital, Angers at 5 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subarachnoid Hemorrhage, Hydrocephalus, Intracranial Hypertension
- What is being tested?
- Direct clamping of external ventricular drain and Progressive (gradual) weaning of external ventricular drain
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 5 sitesFrance
- Study dates
- 1 Jul 2026to 1 Oct 2031
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- 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
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
France5 sites
University Hospital Angers
Angers
Maeva CAMPFORT, MD
University Hospital Brest
Brest
Olivier LANGERON, MD PhD
University Hospital Nantes
Nantes
Antoine ROQUILLY, MD PhD
University Hospital Poitiers
Poitiers
Claire DAHYOT-FIZELIER, MD PhD
University Hospital Rennes
Rennes
Yoann LAUNEY, MD PhD
About this study
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.
Read the detailed description
SEVDVE-2 is a multicenter, randomized, controlled, parallel-group, single-blind superiority trial conducted in French university hospital neurocritical care units (research involving routine-care interventions).
Background and rationale: External ventricular drainage is commonly used in patients with non-traumatic subarachnoid hemorrhage to manage hydrocephalus and/or intracranial hypertension. Prolonged external ventricular drain maintenance is associated with infectious and other complications and prolongs hospital stay. There is no recommendation on the optimal weaning strategy. A retrospective multicenter cohort (SEVDVE) by the investigators showed heterogeneous practices (61% gradual weaning, 39% direct clamping) and suggested that direct clamping shortens the external ventricular drain maintenance duration but is associated with more clamping failures. The investigators have developed standardized daily weanability criteria to better define the timing of the weaning attempt.
Intervention: Eligible adult patients hospitalized in critical care for non-traumatic subarachnoid hemorrhage with a first external ventricular drain in place for less than 3 days are randomized 1:1 (stratified on the presence of intraventricular hematoma) to one of two strategies:
- Direct clamping (experimental arm): from Day 4, daily screening of weanability criteria (no episode of intracranial hypertension for the previous 24 hours, minimal sedation, external ventricular drain 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 for 48 hours.
- Gradual weaning (control arm): when the patient improves (neurological improvement for at least 48 hours, no intracranial hypertension), the external ventricular drain level is raised by 5 mmHg per day. When the external ventricular drain level is ≥20 mmHg and tolerated for 24 hours, the external ventricular drain is clamped for 48 hours.
In both arms, the external ventricular drain is removed after 48 hours of clamping if no neurological deterioration, intracranial hypertension, cerebrospinal fluid leak, or ventricular enlargement occurs. If clamping fails, drainage is resumed and a new attempt is made under the same strategy, within the 28 days after the start of weaning. After Day 14, internalization (ventriculoperitoneal or ventriculoatrial shunt) is to be discussed after two clamping failures.
Patients are blinded to their randomization group. Care providers, investigators, and outcome assessors cannot be blinded because the procedure involves device handling.
Study visits: V1 inclusion visit, daily follow-up between V1 and V2, V2 at hospital discharge or Day 28 ± 3 days, V3 telephone interview at Day 90 ± 7 days. All collected data are those routinely recorded during standard care.
Sample size: 170 patients (85 per arm), based on an expected difference of 3 EVD-free days at Day 28 (13 vs 10), standard deviation 6 days, alpha 5%, power 90%.
- Conditions
- Subarachnoid Hemorrhage, Hydrocephalus, Intracranial Hypertension, External Ventricular Drainage
- Being tested
- Direct clamping of external ventricular drain, Progressive (gradual) weaning of external ventricular drain
- Keywords
- External Ventricular Drain, Subarachnoid Hemorrhage, Weaning; Hydrocephalus, Intracranial Pressure, Neurocritical Care, Direct Clamping, Gradual Weaning, Randomized Controlled Trial
- Medical subject headings
- Subarachnoid Hemorrhage, Hydrocephalus, Intracranial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct clamping of external ventricular drainProcedure or surgery
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.
Progressive (gradual) weaning of external ventricular drainGenetic
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.
| Study group | Role | What they receive |
|---|---|---|
| Direct clamping | Experimental | 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. Receives: Procedure: Direct clamping of external ventricular drain |
| Progressive (gradual) weaning | Active comparator | 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. Receives: Genetic: Progressive (gradual) weaning of external ventricular drain |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28 days after inclusion
Secondary outcomes (9)
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.
Measured: From inclusion up to hospital discharge or Day 90 after inclusion, whichever comes first
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.
Measured: From start of weaning until 72 hours after external ventricular drain removal
Proportion of patients requiring permanent cerebrospinal fluid shunt (internalization)
Proportion of patients in whom a ventriculoperitoneal or ventriculoatrial shunt is placed.
Measured: Up to Day 90 after inclusion
Length of stay in critical care unit
Number of days from admission to critical care to discharge from critical care.
Measured: Up to Day 90 after inclusion
Length of hospital stay
Number of days from hospital admission to hospital discharge.
Measured: Up to Day 90 after inclusion
Modified Rankin Scale score at Day 90
Functional neurological outcome assessed by the modified Rankin Scale (range 0-6, with higher scores indicating greater disability), collected by structured telephone interview with the patient or a relative.
Measured: Day 90 ± 7 days after inclusion
All-cause mortality at Day 28
Proportion of patients who died from any cause by Day 28 after inclusion.
Measured: Day 28 after inclusion
All-cause mortality at Day 90
Proportion of patients who died from any cause by Day 90 after inclusion.
Measured: Day 90 after inclusion
Number of days alive and at home at Day 90
Number of days the patient was alive and living at his/her usual home (i.e., not in a hospital, rehabilitation center, or other healthcare facility) within the 90 days following inclusion.
Measured: Day 90 after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2026
- Study start1 Jul 2026 (estimated)
- Primary completion1 Jul 2030 (estimated)
- Study completion1 Oct 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subarachnoid HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter, randomized, controlled, parallel-group, single-blind superiority trial comparing two strategies for weaning the external ventricular drain in adult patients admitted to critical care for non-traumatic subarachnoid hemorrhage. Allocation is 1:1, stratified on the presence of intraventricular hematoma. The randomization sequence is generated by an independent biostatistician using variable block sizes, and centrally implemented through the secured Ennov Clinical electronic system.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07630051
- Sponsor's protocol ID
- 49RC25_0450
- Other IDs
- 2026-A00901-50
- Acronym
- SEVDVE2
- Status last verified
- Jun 2026
- First submitted
- 1 Jun 2026
- Last updated
- 5 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.