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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control intervention | Active Comparator | Prompt closure, based on best available scientific data |
|
| Experimental intervention | Experimental | Gradual weaning, based on best available scientific data |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control intervention | Procedure | Prompt closure of EVD with subsequent observation period |
|
| 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 |
| 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) |
| 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 |
Inclusion criteria
Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Tiit I Mathiesen, DMSc | Department of Neurosurgery, Copenhagen University Hospital Rigshospitalet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Neurosurgery, Odense University Hospital | Odense | Region Syd | 5000 | Denmark | ||
| Department of Neurosurgery, Copenhagen University Hospital Rigshospitalet |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39010208 | Derived | 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. | |
| 37165711 |
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Data wille be available upon reasonable request and only after approval from local authorities and involving parties.
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| ID | Term |
|---|---|
| D013345 | Subarachnoid Hemorrhage |
| D006849 | Hydrocephalus |
| ID | Term |
|---|---|
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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1:1 randomisation
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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
| Experimental intervention | Procedure | Gradual weaning of EVD with 5 cmH2O increase in drainage resistance daily until complete closure with subsequent observation period |
|
|
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 |
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) |
| 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) |
| 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) |
| Copenhagen |
| 2100 |
| Denmark |
| Department of Neurosurgery, Oslo University Hospital | Oslo | Norway |
| Department of Neurosurgery, University Hospital of North Norway | Tromsø | Norway |
| 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. |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |