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

Overview

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.

Full Title of Study: “Danish RAndomized Trial of External Ventricular Drainage Cessation IN Aneurysmal Subarachnoid Haemorrhage (DRAIN)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: December 31, 2023

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

Arms, Groups and Cohorts

  • Active Comparator: Control intervention
    • Prompt closure, based on best available scientific data
  • Experimental: Experimental intervention
    • Gradual weaning, based on best available scientific data

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Number of serious adverse events (SAE) not including death
    • Time Frame: 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)
  • Health-related quality of life (EQ-5D-5L)
    • Time Frame: 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)

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Rigshospitalet, Denmark
  • Provider of Information About this Clinical Study
    • Principal Investigator: Tiit Mathiesen, Principal investigator – Rigshospitalet, Denmark
  • Overall Official(s)
    • Tiit I Mathiesen, DMSc, Principal Investigator, Department of Neurosurgery, Copenhagen University Hospital Rigshospitalet
  • Overall Contact(s)
    • Tenna Capion, MD, (+45)22772588, tenna.baek.capion@regionh.dk

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