Clinical trial NCT03948256: Danish RAndomized Trial of External Ventricular Drainage Cessation IN Aneurysmal Subarachnoid Haemorrhage
Official title: Danish RAndomized Trial of External Ventricular Drainage Cessation IN Aneurysmal Subarachnoid Haemorrhage (DRAIN)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aneurysmal Subarachnoid Hemorrhage
Hydrocephalus
Keywords: External ventricular drain
Weaning
Closure
Controlled trial
Randomised trial
Outcome assessment blinded
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2019-05-13
Enrollment: 245
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1:1 randomisation
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: VP-shunt implantation, all-cause mortality, or EVD-related infection.
timeFrame: 6 months after ictus
Secondary outcomes:
measure: Number of serious adverse events (SAE) not including death
timeFrame: 6 months after ictus
measure: Health-related quality of life (EQ-5D-5L)
timeFrame: 6 months after ictus
Other outcomes:
measure: Functional outcome according to modified Rankin Scale
timeFrame: 6 months after ictus
measure: The remaining dimensions of EQ-5D-5L
timeFrame: 6 months after ictus
measure: Fatigue Severity Scale (FSS)
timeFrame: 6 months after ictus
measure: Glasgow Outcome Scale Extended (GOSE)
timeFrame: 6 months after ictus
measure: Reason for failure of EVD cessation
timeFrame: At time of failure (assessed up to 6 months)
measure: Glasgow Coma Score (GCS) on discharge from the Neuro Intensive Care Unit and Neurosurgical department (3-15 scale, 15 being the best possible outcome)
timeFrame: At time of discharge (assessed up to 6 months)
measure: Length of stay in Neuro Intensive Care Unit and hospital
timeFrame: At time of discharge (assessed up to 6 months)
Locations:
city: Odense
country: Denmark
facility: Department of Neurosurgery, Odense University Hospital
state: Region Syd
city: Copenhagen
country: Denmark
facility: Department of Neurosurgery, Copenhagen University Hospital Rigshospitalet
city: Oslo
country: Norway
facility: Department of Neurosurgery, Oslo University Hospital
city: Tromsø
country: Norway
facility: Department of Neurosurgery, University Hospital of North Norway
Study officials:
affiliation: Department of Neurosurgery, Copenhagen University Hospital Rigshospitalet
name: Tiit I Mathiesen, DMSc
role: PRINCIPAL_INVESTIGATOR
References: