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

NCT03948256 | Completed

• 1 other identifier: H-18054954
• Study Type: interventional
• Target: 245
• Locations: 2 countries
• Sites: 4

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.

Conditions

Aneurysmal Subarachnoid Hemorrhage; Hydrocephalus

Keywords

External ventricular drain; Weaning; Closure; Controlled trial; Randomised trial; Outcome assessment blinded

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Number of serious adverse events (SAE) not including death

  6 months after ictus

• Health-related quality of life (EQ-5D-5L)

  6 months after ictus

Other Outcomes (7)

• Functional outcome according to modified Rankin Scale

  6 months after ictus

• The remaining dimensions of EQ-5D-5L

  6 months after ictus

• Fatigue Severity Scale (FSS)

  6 months after ictus

Study Arms (2)

Control intervention

ACTIVE COMPARATOR

Prompt closure, based on best available scientific data

Procedure: Control intervention

Experimental intervention

EXPERIMENTAL

Gradual weaning, based on best available scientific data

Procedure: Experimental intervention

Interventions

Control intervention PROCEDURE

Prompt closure of EVD with subsequent observation period

Also known as: Prompt closure

Control intervention

Experimental intervention PROCEDURE

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

Also known as: Gradual weaning

Experimental intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>= 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (4)

Department of Neurosurgery, Odense University Hospital

Odense, Region Syd, 5000, Denmark

Location

Department of Neurosurgery, Copenhagen University Hospital Rigshospitalet

Copenhagen, 2100, Denmark

Location

Department of Neurosurgery, Oslo University Hospital

Oslo, Norway

Location

Department of Neurosurgery, University Hospital of North Norway

Tromsø, Norway

Location

Related Publications (2)

• Capion T, Lilja-Cyron A, Juhler M, Moller K, Sorteberg A, Ronning PA, Poulsen FR, Wismann J, Schack AE, Ravlo C, Isaksen J, Lindschou J, Gluud C, Mathiesen T, Olsen MH. Prompt closure versus gradual weaning of external ventricular drain for hydrocephalus following aneurysmal subarachnoid haemorrhage: a statistical analysis plan for the DRAIN randomised clinical trial. Trials. 2024 Jul 15;25(1):479. doi: 10.1186/s13063-024-08305-4.

  PMID: 39010208 DERIVED

• Capion T, Lilja-Cyron A, Olsen MH, Juhler M, Moller K, Sorteberg A, Ronning PA, Poulsen FR, Wismann J, Ravlo C, Isaksen J, Lindschou J, Gluud C, Mathiesen T. Prompt closure versus gradual weaning of external ventricular drainage for hydrocephalus following aneurysmal subarachnoid haemorrhage: Protocol for the DRAIN randomised clinical trial. Acta Anaesthesiol Scand. 2023 Sep;67(8):1121-1127. doi: 10.1111/aas.14263. Epub 2023 May 10.

  PMID: 37165711 DERIVED

MeSH Terms

Conditions

Subarachnoid Hemorrhage; Hydrocephalus

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Tiit I Mathiesen, DMSc

  Department of Neurosurgery, Copenhagen University Hospital Rigshospitalet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: 1:1 randomisation

Study Record Dates

• First Submitted: April 4, 2019
• First Posted: May 13, 2019
• Study Start: June 6, 2019
• Primary Completion: June 18, 2024
• Study Completion: June 18, 2024
• Last Updated: June 25, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2); NO (2)