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

Sponsor

Rigshospitalet, Denmark (Other)

Overall Status

Recruiting

CT.gov ID

NCT03948256

Collaborator

(none)

244

Enrollment

Location

Arms

55.9

Anticipated Duration (Months)

4.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Aneurysmal Subarachnoid Hemorrhage Hydrocephalus	Procedure: Control intervention Procedure: Experimental intervention	N/A

Detailed Description

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

244 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

1:1 randomization1:1 randomization

Masking:

Single (Outcomes Assessor)

Masking Description:

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

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 6, 2019

Anticipated Primary Completion Date :

Aug 1, 2023

Anticipated Study Completion Date :

Feb 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Control intervention Prompt closure, based on best available scientific data	Procedure: Control intervention Prompt closure of EVD with subsequent observation period Other Names: Prompt closure
Experimental: Experimental intervention Gradual weaning, based on best available scientific data	Procedure: Experimental intervention Gradual weaning of EVD with 5 cmH2O increase in drainage resistance daily until complete closure with subsequent observation period Other Names: Gradual weaning

Arm

Intervention/Treatment

Active Comparator: Control intervention

Prompt closure, based on best available scientific data

Procedure: Control intervention

Prompt closure of EVD with subsequent observation period

Other Names:

Prompt closure

Experimental: Experimental intervention

Gradual weaning, based on best available scientific data

Procedure: Experimental intervention

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

Other Names:

Gradual weaning

Outcome Measures

Primary Outcome Measures

Any serious adverse event (SAE) including all-cause mortality [6 months after ictus]
Serious adverse events incl. mortality within 6 months after ictus

Secondary Outcome Measures

Serious adverse event (SAE) excl. mortality [6 months after ictus]
Serious adverse events excl. mortality within 6 months after ictus

Other Outcome Measures

Quality of Life measured by scale [6 months after ictus]
European Quality of Life (EQ-5D)
Functional outcome [6 months after ictus]
modified Rankin Scale (mRS)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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