Aneurysmal Subarachnoid HemorrhageDRAINNCT03948256
Danish RAndomized Trial of External Ventricular Drainage Cessation IN Aneurysmal Subarachnoid Haemorrhage
A study testing Experimental intervention in people with Aneurysmal Subarachnoid Hemorrhage and Hydrocephalus, run by Copenhagen University Hospital, Rigshospitalet at 4 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aneurysmal Subarachnoid Hemorrhage, Hydrocephalus
- What is being tested?
- Experimental intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 245 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 6 Jun 2019to 18 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >= 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)
Who cannot join
- 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
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Denmark2 sites
Department of Neurosurgery, Copenhagen University Hospital Rigshospitalet
Copenhagen, 2100
Department of Neurosurgery, Odense University Hospital
Odense, Region Syd, 5000
Norway2 sites
Department of Neurosurgery, Oslo University Hospital
Oslo
Department of Neurosurgery, University Hospital of North Norway
Tromsø
About this study
Official title: Danish RAndomized Trial of External Ventricular Drainage Cessation IN Aneurysmal Subarachnoid Haemorrhage (DRAIN)
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
- Being tested
- Control intervention, Experimental intervention
- Keywords
- External ventricular drain, Weaning, Closure, Controlled trial, Randomised trial, Outcome assessment blinded
- Medical subject headings
- Subarachnoid Hemorrhage, Hydrocephalus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control interventionProcedure or surgery
Also called Prompt closure
Prompt closure of EVD with subsequent observation period
Experimental interventionProcedure or surgery
Also called Gradual weaning
Gradual weaning of EVD with 5 cmH2O increase in drainage resistance daily until complete closure with subsequent observation period
| Study group | Role | What they receive |
|---|---|---|
| Control intervention | Active comparator | Prompt closure, based on best available scientific data Receives: Procedure: Control intervention |
| Experimental intervention | Experimental | Gradual weaning, based on best available scientific data Receives: Procedure: Experimental intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months after ictus
Secondary outcomes (2)
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)
Measured: 6 months after ictus
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)
Measured: 6 months after ictus
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2019
- Study start6 Jun 2019
- Primary completion18 Jun 2024
- Study completion18 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Aneurysmal Subarachnoid HemorrhageStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1:1 randomisation
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 245 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tiit Mathiesen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Tiit I Mathiesen, DMSc, Principal investigator, Department of Neurosurgery, Copenhagen University Hospital Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03948256
- Sponsor's protocol ID
- H-18054954
- Acronym
- DRAIN
- Status last verified
- Jun 2024
- First submitted
- 4 Apr 2019
- Last updated
- 25 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data wille be available upon reasonable request and only after approval from local authorities and involving parties.
Publications
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.
PubMed 39010208Capion 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.
PubMed 37165711
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Danish RAndomized Trial of External Ventricular Drainage Cessation IN Aneurysmal Subarachnoid Haemorrhage (DRAIN)
- ClinicalTrials.gov ID
- NCT03948256
- Acronym / sponsor ID
- DRAIN / H-18054954
- Conditions
- Aneurysmal Subarachnoid Hemorrhage, Hydrocephalus
- Keywords
- External ventricular drain, Weaning, Closure, Controlled trial, Randomised trial, Outcome assessment blinded
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 245 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 6 Jun 2019 (actual)
- Primary completion
- 18 Jun 2024 (actual)
- Study completion
- 18 Jun 2024 (actual)
- First posted
- 13 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 1:1 randomisation
| Arm | Type | Receives |
|---|---|---|
| Control intervention | Active comparator | Procedure: Control interventionPrompt closure, based on best available scientific data |
| Experimental intervention | Experimental | Procedure: Experimental interventionGradual weaning, based on best available scientific data |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- >= 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control interventionAlso: Prompt closurePrompt closure of EVD with subsequent observation period | Procedure or surgery | Control intervention |
| Experimental interventionAlso: Gradual weaningGradual weaning of EVD with 5 cmH2O increase in drainage resistance daily until complete closure with subsequent observation period | Procedure or surgery | Experimental intervention |
Primary outcome
VP-shunt implantation, all-cause mortality, or EVD-related infection.
Time frame: 6 months after ictus
The primary outcome is a composite outcome of VP-shunt implantation, all-cause mortality, and EVD-related infection.
2 secondary outcomes
Number of serious adverse events (SAE) not including death
Time frame: 6 months after ictus
Health-related quality of life (EQ-5D-5L)
Time frame: 6 months after ictus
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2024.
- Derived from this study: PubMed 39010208Capion 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.
- Derived from this study: PubMed 37165711Capion 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.
- Individual participant dataSharing planned: No. Data wille be available upon reasonable request and only after approval from local authorities and involving parties.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tiit I Mathiesen, DMSc principal investigator
Department of Neurosurgery, Copenhagen University Hospital Rigshospitalet
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental intervention in people with Aneurysmal Subarachnoid Hemorrhage and Hydrocephalus, run by Copenhagen University Hospital, Rigshospitalet at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Denmark, Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VP-shunt implantation, all-cause mortality, or EVD-related infection. (time frame: 6 months after ictus). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03948256, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2024.