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Strategies for Weaning From External Ventricular Drainage (SEVDVE2)

1. juni 2026 opdateret af: University Hospital, Angers

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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%.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

170

Fase

  • Ikke anvendelig

Kontakter og lokationer

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Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Frankrig
      • Angers, Frankrig
        • University Hospital Angers
        • Kontakt:
          • Maeva CAMPFORT, MD
      • Brest, Frankrig
        • University Hospital Brest
        • Kontakt:
          • Olivier LANGERON, MD PhD
      • Nantes, Frankrig
        • University Hospital Nantes
        • Kontakt:
          • Antoine ROQUILLY, MD PhD
      • Poitiers, Frankrig
        • University Hospital Poitiers
        • Kontakt:
          • Claire DAHYOT-FIZELIER, MD PhD
      • Rennes, Frankrig
        • University Hospital Rennes
        • Kontakt:
          • Yoann LAUNEY, MD PhD

Deltagelseskriterier

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Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

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Ingen

Beskrivelse

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Direct clamping
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.
Procedure: Direct clamping of external ventricular drain
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.
Aktiv komparator: Progressive (gradual) weaning
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.
Genetisk: Progressive (gradual) weaning of external ventricular drain
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of external ventricular drain-free days alive at Day 28
Tidsramme: 28 days after inclusion
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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Proportion of patients with external ventricular drain-related infection
Tidsramme: From inclusion up to hospital discharge or Day 90 after inclusion, whichever comes first
Proportion of patients meeting the Centers for Disease Control and Prevention criteria for meningitis or ventriculitis.
From inclusion up to hospital discharge or Day 90 after inclusion, whichever comes first
Proportion of patients with weaning failure
Tidsramme: From start of weaning until 72 hours after external ventricular drain removal
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.
From start of weaning until 72 hours after external ventricular drain removal
Proportion of patients requiring permanent cerebrospinal fluid shunt (internalization)
Tidsramme: Up to Day 90 after inclusion
Proportion of patients in whom a ventriculoperitoneal or ventriculoatrial shunt is placed.
Up to Day 90 after inclusion
Length of stay in critical care unit
Tidsramme: Up to Day 90 after inclusion
Number of days from admission to critical care to discharge from critical care.
Up to Day 90 after inclusion
Length of hospital stay
Tidsramme: Up to Day 90 after inclusion
Number of days from hospital admission to hospital discharge.
Up to Day 90 after inclusion
Modified Rankin Scale score at Day 90
Tidsramme: Day 90 ± 7 days after inclusion
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.
Day 90 ± 7 days after inclusion
All-cause mortality at Day 28
Tidsramme: Day 28 after inclusion
Proportion of patients who died from any cause by Day 28 after inclusion.
Day 28 after inclusion
All-cause mortality at Day 90
Tidsramme: Day 90 after inclusion
Proportion of patients who died from any cause by Day 90 after inclusion.
Day 90 after inclusion
Number of days alive and at home at Day 90
Tidsramme: Day 90 after inclusion
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.
Day 90 after inclusion

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University Hospital, Angers

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juli 2026

Primær færdiggørelse (Anslået)

1. juli 2030

Studieafslutning (Anslået)

1. oktober 2031

Datoer for studieregistrering

Først indsendt

1. juni 2026

Først indsendt, der opfyldte QC-kriterier

1. juni 2026

Først opslået (Faktiske)

5. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 49RC25_0450
  • 2026-A00901-50 (Anden identifikator: ID-RCB)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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.

IPD-delingstidsramme

The data will be shared after signing a negotiated data transfer agreement ( data access agreement), for the duration specified in the agreement.

IPD-delingsadgangskriterier

The data will be made available via secure transfer (sharing platform approved by the university hospital: BlueFiles or Oodrive).

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL

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