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

NCT03948256 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 245

Last updated 2024-06-25

No results posted yet for this study

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.

Conditions

  • Aneurysmal Subarachnoid Hemorrhage
  • Hydrocephalus

Interventions

PROCEDURE

Control intervention

Prompt closure of EVD with subsequent observation period

PROCEDURE

Experimental intervention

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

Sponsors & Collaborators

  • Rigshospitalet, Denmark

    lead OTHER

Principal Investigators

  • Tiit I Mathiesen, DMSc · Department of Neurosurgery, Copenhagen University Hospital Rigshospitalet

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-06
Primary Completion
2024-06-18
Completion
2024-06-18

Countries

  • Denmark
  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03948256 on ClinicalTrials.gov