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

Rigshospitalet

Status: Completed

Conditions: Hydrocephalus; Aneurysmal Subarachnoid Hemorrhage

Treatments: Procedure: Control intervention; Procedure: Experimental intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT03948256

H-18054954

Details and patient eligibility

About

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.

Enrollment: 245 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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245 participants in 2 patient groups

Control intervention

Active Comparator group

Description:

Prompt closure, based on best available scientific data

Treatment:

Procedure: Control intervention

Experimental intervention

Experimental group

Description:

Gradual weaning, based on best available scientific data

Treatment:

Procedure: Experimental intervention