Aneurysmal Subarachnoid Hemorrhage, Hydrocephalus
Conditions
Keywords
External ventricular drain, Weaning, Closure, Controlled trial, Randomised trial, Outcome assessment blinded
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.
Interventions
PROCEDUREControl intervention
Prompt closure of EVD with subsequent observation period
PROCEDUREExperimental intervention
Gradual weaning of EVD with 5 cmH2O increase in drainage resistance daily until complete closure with subsequent observation period
Sponsors
Rigshospitalet, Denmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
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
Intervention model description
1:1 randomisation
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| VP-shunt implantation, all-cause mortality, or EVD-related infection. | 6 months after ictus | The primary outcome is a composite outcome of VP-shunt implantation, all-cause mortality, and EVD-related infection. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of serious adverse events (SAE) not including death | 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) | 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) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Glasgow Outcome Scale Extended (GOSE) | 6 months after ictus | Glasgow Outcome Scale Extended (GOSE) at 6 months (1-8 scale, 8 being the best possible outcome) (ordered categorical outcome) |
| Reason for failure of EVD cessation | At time of failure (assessed up to 6 months) | Reason for failure of EVD cessation (ICP elevation, drop in GCS by 2 points or more, and/or clinical deterioration) |
| Functional outcome according to modified Rankin Scale | 6 months after ictus | Functional outcome according to mRS at 6 months, (1-6 scale, 1 being the best possible outcome)) (ordered categorical outcome) |
| Length of stay in Neuro Intensive Care Unit and hospital | At time of discharge (assessed up to 6 months) | Length of stay in Neuro Intensive Care Unit and hospital |
| 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) | Glasgow Coma Score (GCS) on discharge from the Neuro Intensive Care Unit and Neurosurgical department (3-15 scale, 15 being the best possible outcome) |
| The remaining dimensions of EQ-5D-5L | 6 months after ictus | 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) |
| Fatigue Severity Scale (FSS) | 6 months after ictus | Fatigue Severity Scale (FSS) at 6 months (1-7 scale, 1 being the best possible outcome) (ordered categorical outcome) |
Countries
Denmark, Norway
Outcome results
None listed