Danish RAndomized Trial of External Ventricular Drainage Cessation IN Aneurysmal Subarachnoid Haemorrhage

Study Overview
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Brief Summary
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The DRAIN trial is an international multi-centre, 1:1 randomised, parallel-group, superiority clinical trial investigating gradual weaning vs. prompt closure of external ventricular drainage in patients with hydrocephalus following aSAH. The primary objective is to investigate the beneficial and harmful effects of gradual weaning versus prompt closure of EVD treatment in patients with aSAH.

Official Title
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Danish RAndomized Trial of External Ventricular Drainage Cessation IN Aneurysmal Subarachnoid Haemorrhage (DRAIN)

Conditions
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Aneurysmal Subarachnoid Hemorrhage, Hydrocephalus

Intervention / Treatment
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* Procedure: Control intervention
* Procedure: Experimental intervention


Participation Criteria
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Eligibility Criteria
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Inclusion criteria >= 18 years of age Diagnosis of aneurysmal subarachnoid haemorrhage (aSAH) External ventricular drain (EVD) for >= 6 days Drain output of =< 220 mL on day of randomisation Drain resistance of 10 or 15 cm H2O Stable or improving Glasgow Coma Scale (GCS) >= 9 during the last 24 hours Signed informed consent (from patient or next-of-kin) Exclusion criteria None-tolerability of an increase of resistance to 10 cm H2O due to clinical deterioration or an increase in ICP Severe pre-existing (physical or mental) disability or severe co-morbidity that would lead to poor outcome even if the patient made a full recovery from the aSAH Life expectancy shorter than 48 hours after admission

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 1:1 randomisation
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control intervention<br>Prompt closure, based on best available scientific data | Procedure: Control intervention<br>* Prompt closure of EVD with subsequent observation period<br>* Other names: Prompt closure;|
| Experimental: Experimental intervention<br>Gradual weaning, based on best available scientific data | Procedure: Experimental intervention<br>* Gradual weaning of EVD with 5 cmH2O increase in drainage resistance daily until complete closure with subsequent observation period<br>* Other names: Gradual weaning;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VP-shunt implantation, all-cause mortality, or EVD-related infection. | The primary outcome is a composite outcome of VP-shunt implantation, all-cause mortality, and EVD-related infection. | 6 months after ictus | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of serious adverse events (SAE) not including death | Number of serious adverse events (SAE) not including death as defined according to International Conference of Harmonization of Good Clinical Practice (ICH-GCP) at 6 months (count outcome) | 6 months after ictus | 
| Health-related quality of life (EQ-5D-5L) | Health-related quality of life (EQ-5D-5L) at 6 months with the primary assessment being self- assessment of own health (EQ VAS; 0 to 100 point scale, 100 being the best possible outcome)) (continuous outcome) | 6 months after ictus | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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External ventricular drain, Weaning, Closure, Controlled trial, Randomised trial, Outcome assessment blinded