Subarachnoid HemorrhagePhase 2LUMASNCT00842049
Lumbar Drainage in Subarachnoid Haemorrhage
A Phase 2 study testing Lumbar Drain (Medtronic lumbar drainage system) and No lumbar drain in people with Subarachnoid Hemorrhage, run by The Leeds Teaching Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
Subarachnoid haemorrhage affects approximately 8000 people per year in the UK. The average age of a patient with subarachnoid haemorrhage is 50 years, although it is often seen in younger people (25-45 years). 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 (Medtronic lumbar drainage system) and No lumbar drain
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2006to Jul 2010
- Phase
- Phase 2
- 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
- Aneurysmal subarachnoid haemorrhage.
- Recruitment prior to day three post-haemorrhage.
- Written informed consent or relative assent given.
- WFNS grade 1-3.
- Fisher grade 2, 3 and 4 (without space occupying haematoma) on initial CT scan.
- No intraventricular haemorrhage, space occupying haematoma or other contra-indication to lumbar puncture.
Who cannot join
- Non-aneurysmal subarachnoid haemorrhage.
- Delayed presentation / recruitment (after day three post-haemorrhage)
- Written informed consent or relative assent denied or unobtainable.
- WFNS grade 4 or 5.
- Fisher grade 1 on initial CT scan.
- Intraventricular haematoma obstructing ventricular outflow.
- Intracranial haematoma with mass effect.
- Bleeding diathesis.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Leeds General Infirmary
Leeds, West Yorkshire, LS1 3EX
About this study
Official title: Lumbar Drainage of Cerebrospinal Fluid in Aneurysmal Subarachnoid Haemorrhage: A Prospective Randomised Controlled Trial
Subarachnoid haemorrhage affects approximately 8000 people per year in the UK. The average age of a patient with subarachnoid haemorrhage is 50 years, although it is often seen in younger people (25-45 years). Despite modern medicine, the death and disability rate remains high both from the initial bleed and from the associated complications such as vasospasm. This is characterised by neurological impairment seen following the bleed. Despite modern treatment this is still associated with a poor outcome. This has significant implications due to the long term intensive neuro-rehabilitation these patients will require.
A recent study has shown that placing a small drain in the lower back following a subarachnoid haemorrhage may reduce the chance of vasospasm occurring and result in a better outcome. This trial was not optimally performed and so a trial is needed to look at this in more detail. The investigators have set up such a trial in our neurosurgical unit. If the investigators confirm that there is an improvement in patient outcome, it will change our practice in the future.
Read the detailed description
All patients who present to our department with proven aneurysmal SAH and fit the inclusion criteria (see below) will be approached for inclusion into the trial. Written informed consent will be sought prior to recruitment into the study. Written assent from the patient's relatives will be sought in those cases where neurological impairment prevents written informed consent being obtained from the patient. The patient will subsequently be randomised into the control arm or the study arm of the trial. The control arm consists of normal therapeutic intervention, including external ventricular drainage if required for hydrocephalus. Those randomised to the therapeutic arm will have a lumbar drain inserted and set to drain CSF at 5 ml/hour. This will continue until CSF is no longer blood stained or until day 10 following insertion.
Primary outcome measures:
- Incidence of delayed ischaemic neurological deficit. This is defined as new neurological deficit and/or impairment of consciousness without other identifiable cause at least three days post haemorrhage.
New impairment of consciousness is defined as a drop in the Glasgow Coma Score of 1 motor point or 2 verbal/eye opening points.
Secondary outcome measures:
- Modified Rankin Score at day 10 post ictus and at 6 months.
- Severity of delayed neurological deficit and the development of a complete infarct.
- Incidence of cerebrospinal fluid infection secondary to lumbar drainage
Special note:
If a patient has presented greater than three days following the initial bleed, any neurological deficit present may be a delayed neurological deficit and thus must be excluded from the trial. Should the lumbar drain fall out prematurely the patient will be asked whether they wish to continue in the study and, if so, the lumbar drain will be reinserted and management will continue as before. Patients showing signs of lumbar drain infection will have the drain removed, a sample of CSF and the drain tip sent to the microbiology laboratory and appropriate antibiotic therapy instituted.
The neurosurgical unit at Leeds General Infirmary treated 313 patients with acute subarachnoid haemorrhage in the three years 1997-2000. Of these 243 patients would have been suitable for this study on the basis of their admission clinical status. The power calculation was derived from the estimate that 40% of patients treated with standard therapy will develop clinical vasospasm. If the retrospective study showed a minimum of 20% improvement in its outcome variables then we expect to see the same improvement. For an 85% power this requires 105 patients in each arm. We expect this to take 3.5 years based on the number of eligible patients that present to our unit with a 60-70% recruitment rate (approximately 30 patients per year per arm).
- Conditions
- Subarachnoid Hemorrhage
- Being tested
- Lumbar Drain (Medtronic lumbar drainage system), No lumbar drain
- Keywords
- Subarachnoid haemorrhage, Aneurysm, Cerebrospinal fluid drainage
- Medical subject headings
- Subarachnoid Hemorrhage, Aneurysm, Cerebrospinal Fluid Leak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumbar Drain (Medtronic lumbar drainage system)Device
Also called Medtronic lumbar drainage system
Insertion of lumbar drain to drain cerebrospinal fluid
No lumbar drainOther
No lumbar drain
| Study group | Role | What they receive |
|---|---|---|
| Study | Experimental | Insertion of lumbar drain Receives: Device: Lumbar Drain (Medtronic lumbar drainage system) |
| Control | Other | Normal clinical management without lumbar drain Receives: Other: No lumbar drain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of delayed ischaemic neurological deficit
Measured: Within 21 days of haemorrhagic ictus
Secondary outcomes (4)
Modified Rankin Score
Measured: 10 days and 6 months following haemorrhagic ictus
Incidence of cerebrospinal fluid shunting
Measured: Within 12 months of haemorrhagic ictus
Incidence of completed infarct secondary to delayed ischaemic neurological deficit
Measured: Within 21 days of ictus
Incidence of cerebrospinal fluid infection secondary to lumbar drainage
Measured: Within 8 weeks of removal of lumbar drain
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2009 (estimated)
- Study startNov 2006
- Primary completionJul 2010
- Study completionJul 2010
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 Subarachnoid HemorrhageStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Leeds Teaching Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yahia Al-Tamimi, MCChB(Hons), Principal investigator, Leeds Teaching Hospital NHS TrustStuart Ross, FRCS(SN), Study director, Leeds Teaching Hospital NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00842049
- Sponsor's protocol ID
- 06/Q1205/170
- Acronym
- LUMAS
- Status last verified
- Dec 2023
- First submitted
- 11 Feb 2009
- Last updated
- 22 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Klimo P Jr, Kestle JR, MacDonald JD, Schmidt RH. Marked reduction of cerebral vasospasm with lumbar drainage of cerebrospinal fluid after subarachnoid hemorrhage. J Neurosurg. 2004 Feb;100(2):215-24. doi: 10.3171/jns.2004.100.2.0215.
PubMed 15086227Al-Tamimi YZ, Bhargava D, Feltbower RG, Hall G, Goddard AJ, Quinn AC, Ross SA. Lumbar drainage of cerebrospinal fluid after aneurysmal subarachnoid hemorrhage: a prospective, randomized, controlled trial (LUMAS). Stroke. 2012 Mar;43(3):677-82. doi: 10.1161/STROKEAHA.111.625731. Epub 2012 Jan 26.
PubMed 22282887
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lumbar Drainage of Cerebrospinal Fluid in Aneurysmal Subarachnoid Haemorrhage: A Prospective Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT00842049
- Acronym / sponsor ID
- LUMAS / 06/Q1205/170
- Conditions
- Subarachnoid Hemorrhage
- Keywords
- Subarachnoid haemorrhage, Aneurysm, Cerebrospinal fluid drainage
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- The Leeds Teaching Hospitals NHS TrustUniversity, hospital or other
- Study start
- Nov 2006
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 12 Feb 2009 (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.
Subarachnoid haemorrhage affects approximately 8000 people per year in the UK. The average age of a patient with subarachnoid haemorrhage is 50 years, although it is often seen in younger people (25-45 years). Despite modern medicine, the death and disability rate remains high both from the initial bleed and from the associated complications such as vasospasm. This is characterised by neurological impairment seen following the bleed. Despite modern treatment this is still associated with a poor outcome. This has significant implications due to the long term intensive neuro-rehabilitation these patients will require.
A recent study has shown that placing a small drain in the lower back following a subarachnoid haemorrhage may reduce the chance of vasospasm occurring and result in a better outcome. This trial was not optimally performed and so a trial is needed to look at this in more detail. The investigators have set up such a trial in our neurosurgical unit. If the investigators confirm that there is an improvement in patient outcome, it will change our practice in the future.
Detailed description
All patients who present to our department with proven aneurysmal SAH and fit the inclusion criteria (see below) will be approached for inclusion into the trial. Written informed consent will be sought prior to recruitment into the study. Written assent from the patient's relatives will be sought in those cases where neurological impairment prevents written informed consent being obtained from the patient. The patient will subsequently be randomised into the control arm or the study arm of the trial. The control arm consists of normal therapeutic intervention, including external ventricular drainage if required for hydrocephalus. Those randomised to the therapeutic arm will have a lumbar drain inserted and set to drain CSF at 5 ml/hour. This will continue until CSF is no longer blood stained or until day 10 following insertion.
Primary outcome measures:
- Incidence of delayed ischaemic neurological deficit. This is defined as new neurological deficit and/or impairment of consciousness without other identifiable cause at least three days post haemorrhage.
New impairment of consciousness is defined as a drop in the Glasgow Coma Score of 1 motor point or 2 verbal/eye opening points.
Secondary outcome measures:
- Modified Rankin Score at day 10 post ictus and at 6 months.
- Severity of delayed neurological deficit and the development of a complete infarct.
- Incidence of cerebrospinal fluid infection secondary to lumbar drainage
Special note:
If a patient has presented greater than three days following the initial bleed, any neurological deficit present may be a delayed neurological deficit and thus must be excluded from the trial. Should the lumbar drain fall out prematurely the patient will be asked whether they wish to continue in the study and, if so, the lumbar drain will be reinserted and management will continue as before. Patients showing signs of lumbar drain infection will have the drain removed, a sample of CSF and the drain tip sent to the microbiology laboratory and appropriate antibiotic therapy instituted.
The neurosurgical unit at Leeds General Infirmary treated 313 patients with acute subarachnoid haemorrhage in the three years 1997-2000. Of these 243 patients would have been suitable for this study on the basis of their admission clinical status. The power calculation was derived from the estimate that 40% of patients treated with standard therapy will develop clinical vasospasm. If the retrospective study showed a minimum of 20% improvement in its outcome variables then we expect to see the same improvement. For an 85% power this requires 105 patients in each arm. We expect this to take 3.5 years based on the number of eligible patients that present to our unit with a 60-70% recruitment rate (approximately 30 patients per year per arm).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study | Experimental | Device: Lumbar Drain (Medtronic lumbar drainage system)Insertion of lumbar drain |
| Control | Other | Other: No lumbar drainNormal clinical management without lumbar drain |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aneurysmal subarachnoid haemorrhage.
- Recruitment prior to day three post-haemorrhage.
- Written informed consent or relative assent given.
- WFNS grade 1-3.
- Fisher grade 2, 3 and 4 (without space occupying haematoma) on initial CT scan.
Key exclusion criteria (8 listed)
- Non-aneurysmal subarachnoid haemorrhage.
- Delayed presentation / recruitment (after day three post-haemorrhage)
- Written informed consent or relative assent denied or unobtainable.
- WFNS grade 4 or 5.
- Fisher grade 1 on initial CT scan.
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 (Medtronic lumbar drainage system)Also: Medtronic lumbar drainage systemInsertion of lumbar drain to drain cerebrospinal fluid | Device | Study |
| No lumbar drainNo lumbar drain | Other | Control |
Primary outcome
Incidence of delayed ischaemic neurological deficit
Time frame: Within 21 days of haemorrhagic ictus
4 secondary outcomes
Modified Rankin Score
Time frame: 10 days and 6 months following haemorrhagic ictus
Incidence of cerebrospinal fluid shunting
Time frame: Within 12 months of haemorrhagic ictus
Incidence of completed infarct secondary to delayed ischaemic neurological deficit
Time frame: Within 21 days of ictus
Incidence of cerebrospinal fluid infection secondary to lumbar drainage
Time frame: Within 8 weeks of removal of lumbar drain
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 22 Dec 2023.
- Background: PubMed 15086227Klimo P Jr, Kestle JR, MacDonald JD, Schmidt RH. Marked reduction of cerebral vasospasm with lumbar drainage of cerebrospinal fluid after subarachnoid hemorrhage. J Neurosurg. 2004 Feb;100(2):215-24. doi: 10.3171/jns.2004.100.2.0215.
- Derived from this study: PubMed 22282887Al-Tamimi YZ, Bhargava D, Feltbower RG, Hall G, Goddard AJ, Quinn AC, Ross SA. Lumbar drainage of cerebrospinal fluid after aneurysmal subarachnoid hemorrhage: a prospective, randomized, controlled trial (LUMAS). Stroke. 2012 Mar;43(3):677-82. doi: 10.1161/STROKEAHA.111.625731. Epub 2012 Jan 26.
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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.
Yahia Al-Tamimi, MCChB(Hons) principal investigator
Leeds Teaching Hospital NHS Trust
Stuart Ross, FRCS(SN) study director
Leeds Teaching Hospital NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lumbar Drain (Medtronic lumbar drainage system) and No lumbar drain in people with Subarachnoid Hemorrhage, run by The Leeds Teaching Hospitals NHS Trust at 1 site in United Kingdom.
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 6 inclusion and 8 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 22 Dec 2023. 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 United Kingdom. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Incidence of delayed ischaemic neurological deficit (time frame: Within 21 days of haemorrhagic 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 NCT00842049, 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 22 Dec 2023.