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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Aneurysmal Subarachnoid Hemorrhage; Hydrocephalus
• Intervention / Treatment: Procedure: Control intervention; Procedure: Experimental intervention

Detailed 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

• Study Type: Interventional
• Enrollment (Anticipated): 244
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tenna Capion, MD; Phone Number: (+45)22772588; Email: tenna.baek.capion@regionh.dk

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Recruiting
    • Department of Neurosurgery, Copenhagen University Hospital Rigshospitalet
    • Contact: Tenna Capion, MD; Phone Number: (+45) 35450845; Email: tenna.baek.capion@regionh.dk
    • Contact: Tiit Mathiesen, DMSc; Phone Number: (+45) 35453188; Email: tiit.illimar.mathiesen@regionh.dk
  • Region Syd
    • Odense, Region Syd, Denmark, 5000
      • Recruiting
      • Department of Neurosurgery, Odense University Hospital
      • Contact: Frantz Rom Poulsen
• Norway
  • Oslo, Norway
    • Recruiting
    • Department of Neurosurgery, Oslo University Hospital
    • Contact: Angelika Sorteberg
  • Tromsø, Norway
    • Recruiting
    • Department of Neurosurgery, University Hospital of North Norway
    • Contact: Jørgen Isaksen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional outcome according to modified Rankin Scale	Functional outcome according to mRS at 6 months, (1-6 scale, 1 being the best possible outcome)) (ordered categorical outcome)	6 months after ictus
The remaining dimensions of EQ-5D-5L	The remaining dimensions of EQ-5D-5L (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) at 6 months (1-5 levels, 1 being the best possible outcome) (count outcome)	6 months after ictus
Fatigue Severity Scale (FSS)	Fatigue Severity Scale (FSS) at 6 months (1-7 scale, 1 being the best possible outcome) (ordered categorical outcome)	6 months after ictus
Glasgow Outcome Scale Extended (GOSE)	Glasgow Outcome Scale Extended (GOSE) at 6 months (1-8 scale, 8 being the best possible outcome) (ordered categorical outcome)	6 months after ictus
Reason for failure of EVD cessation	Reason for failure of EVD cessation (ICP elevation, drop in GCS by 2 points or more, and/or clinical deterioration)	At time of failure (assessed up to 6 months)
Length of stay in Neuro Intensive Care Unit and hospital	Length of stay in Neuro Intensive Care Unit and hospital	At time of discharge (assessed up to 6 months)
Glasgow Coma Score (GCS) on discharge from the Neuro Intensive Care Unit and Neurosurgical department (3-15 scale, 15 being the best possible outcome)	Glasgow Coma Score (GCS) on discharge from the Neuro Intensive Care Unit and Neurosurgical department (3-15 scale, 15 being the best possible outcome)	At time of discharge (assessed up to 6 months)

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Investigators: Principal Investigator: Tiit I Mathiesen, DMSc, Department of Neurosurgery, Copenhagen University Hospital Rigshospitalet

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2019
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): July 1, 2024

Study Registration Dates

• First Submitted: April 4, 2019
• First Submitted That Met QC Criteria: May 10, 2019
• First Posted (Actual): May 13, 2019

Study Record Updates

• Last Update Posted (Actual): May 18, 2023
• Last Update Submitted That Met QC Criteria: May 16, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Weaning; Controlled trial; Randomised trial; Closure; External ventricular drain; Outcome assessment blinded
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Hemorrhages; Hemorrhage; Subarachnoid Hemorrhage; Hydrocephalus
• Other Study ID Numbers: H-18054954

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data wille be available upon reasonable request and only after approval from local authorities and involving parties.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No