CompletedNot Applicable

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

Denmark, Norway245 participantsStarted 2019-06-06

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

VP-shunt implantation, all-cause mortality, or EVD-related infection.

Timeframe: 6 months after ictus

Trial details

NCT IDNCT03948256

SponsorRigshospitalet, Denmark

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-06-18

View on ClinicalTrials.gov More Aneurysmal Subarachnoid Hemorrhage trials