External Ventricular Drainage, Hydrocephalus, Intracranial Hypertension, Subarachnoid Hemorrhage
Conditions
Keywords
External Ventricular Drain, Subarachnoid Hemorrhage, Weaning; Hydrocephalus, Intracranial Pressure, Neurocritical Care, Direct Clamping, Gradual Weaning, Randomized Controlled Trial
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.
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%.
Interventions
PROCEDUREDirect 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.
GENETICProgressive (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.
Sponsors
University Hospital, Angers
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
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.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of external ventricular drain-free days alive at Day 28 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 meeting the Centers for Disease Control and Prevention criteria for meningitis or ventriculitis. |
| Proportion of patients with weaning failure | 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. |
| Proportion of patients requiring permanent cerebrospinal fluid shunt (internalization) | Up to Day 90 after inclusion | Proportion of patients in whom a ventriculoperitoneal or ventriculoatrial shunt is placed. |
| Length of stay in critical care unit | Up to Day 90 after inclusion | Number of days from admission to critical care to discharge from critical care. |
| Length of hospital stay | Up to Day 90 after inclusion | Number of days from hospital admission to hospital discharge. |
| Modified Rankin Scale score at Day 90 | 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. |
| All-cause mortality at Day 28 | Day 28 after inclusion | Proportion of patients who died from any cause by Day 28 after inclusion. |
| All-cause mortality at Day 90 | Day 90 after inclusion | Proportion of patients who died from any cause by Day 90 after inclusion. |
| Number of days alive and at home at Day 90 | 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. |
Countries
France
Contacts
CONTACTMaeva CAMPFORT, MD
CONTACTPromotion Interne
Outcome results
None listed