Subarachnoid Hemorrhage.NCT01886521
Use of Lumbar Drain to Remove Clots in Patients Admitted to the Neuro-ICU After Subarachnoid Hemorrhage.
A study testing Lumbar drain and Ventricular drain in people with Subarachnoid Hemorrhage., run by Odense University Hospital at 1 site in Denmark.
Trial summary
Recently, a clinical trial showed that the use of lumbar drains compared to ventricular drain in patients suffering from subarachnoid hemorrhage resulted in less delayed ischemic neurological deficits but failed to show a clinical benefit after 6 months. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subarachnoid Hemorrhage.
- What is being tested?
- Lumbar drain and Ventricular drain
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2013to Sep 2016
- 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
- Patients admitted to the neuro-ICU with aneurysmal subarachnoid hemorrhage
- In need for CSF drainage based on clinical judgment
Who cannot join
- intraventricular clots
- intraparenchymal clots causing midline shift
- pregnancy
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Department of Neurosurgery, Odense University Hospital
Odense, DK-5000
Peter Birkeland, MD, +4560869248, Peter@Birkeland.dk
About this study
Official title: Use of Lumbar Drain Versus Ventricular Drain to Remove Clots in Patients Admitted to the Neuro-ICU After Subarachnoid Hemorrhage (a Randomized Trial).
Recently, a clinical trial showed that the use of lumbar drains compared to ventricular drain in patients suffering from subarachnoid hemorrhage resulted in less delayed ischemic neurological deficits but failed to show a clinical benefit after 6 months. The underlying assumption was, that the cerebrospinal fluid (CSF) obtained from lumbar drains has a higher concentration of blood than CSF from lumbar drains. The investigators decided to test this assumption. In this study, the investigators will randomize patients to either placement of a ventricular or a lumbar drain and analyze the CSF drainage on a daily basis.
- Conditions
- Subarachnoid Hemorrhage.
- Being tested
- Lumbar drain, Ventricular drain
- Medical subject headings
- Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumbar drainProcedure or surgery
Ventricular drainProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Lumbar drain group | Experimental | Lumbar drain Receives: Procedure: Lumbar drain |
| Ventricular drain | Active comparator | Ventricular drain Receives: Procedure: Ventricular drain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accumulated Hb and bilirubin in CSF drainage
Measured: From drain placement to removal, in average 10 days.
Secondary outcomes (3)
placement of a ventriculoperitoneal shunt
Measured: participants will be followed for the duration of hospital stay, in average 3 weeks
Lindegaard ratio (TCD) > 3
Measured: the participants will be followed for the duration of hospital stay, in average 3 weeks
clinical signs of vasospasms
Measured: The participants will be followedd for the duration of hospital stay, in average 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2013 (estimated)
- Study startAug 2013
- Primary completionJun 2016 (estimated)
- Study completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subarachnoid Hemorrhage.Studies of the same condition, open and under way.
- More trials run by Odense University HospitalThe 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
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Birkeland, Odense University Hospital
- Investigators
- Peter Birkeland, MD, Principal investigator, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01886521
- Sponsor's protocol ID
- 37238
- Status last verified
- Oct 2014
- First submitted
- 9 Jun 2013
- Last updated
- 21 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Lumbar Drain Versus Ventricular Drain to Remove Clots in Patients Admitted to the Neuro-ICU After Subarachnoid Hemorrhage (a Randomized Trial).
- ClinicalTrials.gov ID
- NCT01886521
- Acronym / sponsor ID
- 37238
- Conditions
- Subarachnoid Hemorrhage.
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 26 Jun 2013 (estimated)
- 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.
Recently, a clinical trial showed that the use of lumbar drains compared to ventricular drain in patients suffering from subarachnoid hemorrhage resulted in less delayed ischemic neurological deficits but failed to show a clinical benefit after 6 months. The underlying assumption was, that the cerebrospinal fluid (CSF) obtained from lumbar drains has a higher concentration of blood than CSF from lumbar drains. The investigators decided to test this assumption. In this study, the investigators will randomize patients to either placement of a ventricular or a lumbar drain and analyze the CSF drainage on a daily basis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lumbar drain group | Experimental | Procedure: Lumbar drainLumbar drain |
| Ventricular drain | Active comparator | Procedure: Ventricular drainVentricular drain |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients admitted to the neuro-ICU with aneurysmal subarachnoid hemorrhage
- In need for CSF drainage based on clinical judgment
Key exclusion criteria (3 listed)
- intraventricular clots
- intraparenchymal clots causing midline shift
- pregnancy
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 |
|---|---|---|
| Lumbar drain | Procedure or surgery | Lumbar drain group |
| Ventricular drain | Procedure or surgery | Ventricular drain |
Primary outcome
Accumulated Hb and bilirubin in CSF drainage
Time frame: From drain placement to removal, in average 10 days.
3 secondary outcomes
placement of a ventriculoperitoneal shunt
Time frame: participants will be followed for the duration of hospital stay, in average 3 weeks
Lindegaard ratio (TCD) > 3
Time frame: the participants will be followed for the duration of hospital stay, in average 3 weeks
clinical signs of vasospasms
Time frame: The participants will be followedd for the duration of hospital stay, in average 3 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2014.
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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.
Peter Birkeland, MD principal investigator
Odense University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lumbar drain and Ventricular drain in people with Subarachnoid Hemorrhage., run by Odense University Hospital at 1 site in Denmark.
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 2 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: status not confirmed, as of the sponsor's last update on 21 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accumulated Hb and bilirubin in CSF drainage (time frame: From drain placement to removal, in average 10 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Oct 2014.