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

  • STATUS
    Recruiting
  • End date
    Feb 1, 2024
  • participants needed
    244
  • sponsor
    Rigshospitalet, Denmark
Updated on 10 May 2022
drainage

Summary

To assess the benefits and harms of two commonly used regimens for external ventricular drainage cessation in in patients with hydrocephalus following aneurysmal subarachnoid haemorrhage a randomized controlled setting.

Design: Investigator-initiated, multi-centre, 1:1 randomized, parallel group, outcome assessment blinded clinical trial of gradual weaning vs. prompt closure of external ventricular drainage in patients with hydrocephalus following aneurysmal SAH

Description

To assess the benefits and harms of two commonly used regimens for external ventricular drainage cessation in in patients with hydrocephalus following aneurysmal subarachnoid haemorrhage a randomized controlled setting.

Design: Investigator-initiated, international multi-centre, 1:1 randomized, parallel group, outcome assessment blinded clinical trial of gradual weaning vs. prompt closure of external ventricular drainage in patients with hydrocephalus following aneurysmal SAH

Details
Condition Aneurysmal Subarachnoid Hemorrhage, Hydrocephalus
Treatment Experimental intervention, Control intervention
Clinical Study IdentifierNCT03948256
SponsorRigshospitalet, Denmark
Last Modified on10 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Stable or improving neurological status (GCS) during the last 24 hours
No clinical or radiological signs of cerebral vasospasms as delayed neurological deficits (DND) during the last 24 hours
Signed informed consent from patient or next-of-kin

Exclusion Criteria

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 based on clinical investigations
Lack of signed informed consent
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