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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

245 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-06

Study Completion Date

2024-06-18

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.

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Detailed Description

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Conditions

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Aneurysmal Subarachnoid Hemorrhage Hydrocephalus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

1:1 randomisation

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Due to the nature of the intervention with two arms with different time course it is not possible to mask patients nor investigators or care providers

Study Groups

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Control intervention

Prompt closure, based on best available scientific data

Group Type ACTIVE_COMPARATOR

Control intervention

Intervention Type PROCEDURE

Prompt closure of EVD with subsequent observation period

Experimental intervention

Gradual weaning, based on best available scientific data

Group Type EXPERIMENTAL

Experimental intervention

Intervention Type PROCEDURE

Gradual weaning of EVD with 5 cmH2O increase in drainage resistance daily until complete closure with subsequent observation period

Interventions

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Control intervention

Prompt closure of EVD with subsequent observation period

Intervention Type PROCEDURE

Experimental intervention

Gradual weaning of EVD with 5 cmH2O increase in drainage resistance daily until complete closure with subsequent observation period

Intervention Type PROCEDURE

Other Intervention Names

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Prompt closure Gradual weaning

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No