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

Hydrocephalus Clinical Trial

— DRAIN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03948256
• Other study ID #: H-18054954
• Status: Recruiting
• Phase: N/A
• Start date: June 6, 2019
• Est. completion date: July 1, 2024

Study information

• Verified date: May 2023
• Source: Rigshospitalet, Denmark
• Contact: Tenna Capion, MD
• Phone: (+45)22772588
• Email: tenna.baek.capion[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 244
• Est. completion date: July 1, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aneurysmal Subarachnoid Hemorrhage
• Hemorrhage
• Hydrocephalus
• Subarachnoid Hemorrhage

Intervention

Procedure:
• Control intervention
Prompt closure of EVD with subsequent observation period
• Experimental intervention
Gradual weaning of EVD with 5 cmH2O increase in drainage resistance daily until complete closure with subsequent observation period

Locations

Country	Name	City	State
Denmark	Department of Neurosurgery, Copenhagen University Hospital Rigshospitalet	Copenhagen
Denmark	Department of Neurosurgery, Odense University Hospital	Odense	Region Syd
Norway	Department of Neurosurgery, Oslo University Hospital	Oslo
Norway	Department of Neurosurgery, University Hospital of North Norway	Tromsø

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Countries where clinical trial is conducted

Denmark,  Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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)
Other	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)
Other	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)
Primary	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	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
Secondary	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