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

Rigshospitalet, Denmark245 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

245

Conditions

Aneurysmal Subarachnoid Hemorrhage Hydrocephalus

Interventions

Control interventionPROCEDURE

Prompt closure of EVD with subsequent observation period

Experimental interventionPROCEDURE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (4)

Department of Neurosurgery, Odense University Hospital

Odense, Region Syd, Denmark

Department of Neurosurgery, Copenhagen University Hospital Rigshospitalet

Copenhagen, Denmark

Department of Neurosurgery, Oslo University Hospital

Oslo, Norway

Department of Neurosurgery, University Hospital of North Norway

Tromsø, Norway

Outcomes

Primary Outcomes

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.

Time frame: 6 months after ictus

Secondary Outcomes

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)

Time frame: 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)

Time frame: 6 months after ictus

Data from ClinicalTrials.gov

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