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

Not Applicable

Completed

• Conditions: Hydrocephalus; Aneurysmal Subarachnoid Hemorrhage
• Interventions: Procedure: Experimental intervention; Procedure: Control intervention

• Registration Number: NCT03948256
• Lead Sponsor: Rigshospitalet, Denmark

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-04-04
• Study First Submitted QC: 2019-05-10
• Study First Posted: 2019-05-13
• Study Start: 2019-06-06
• Status Verified: 2024-06
• Primary Completion: 2024-06-18
• Study Completion: 2024-06-18
• Last Update Submitted: 2024-06-24
• Last Update Posted: 2024-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 245

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental intervention	Experimental intervention	Gradual weaning, based on best available scientific data
Control intervention	Control intervention	Prompt closure, based on best available scientific data

Primary Outcome Measures

Name	Time	Method
VP-shunt implantation, all-cause mortality, or EVD-related infection.	6 months after ictus	The primary outcome is a composite outcome of VP-shunt implantation, all-cause mortality, and EVD-related infection.

Secondary Outcome Measures

Name	Time	Method
Health-related quality of life (EQ-5D-5L)	6 months after ictus	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)
Number of serious adverse events (SAE) not including death	6 months after ictus	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)

Trial Locations

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