Brain IschemiaPhase 2/3NCT01407614
The Tilburg Vasospasm Study
A Phase 2/3 study testing external lumbar drainage (ELD) of cerebrospinal fluid in people with Brain Ischemia and Intracranial Vasospasm, run by Elisabeth-TweeSteden Ziekenhuis at 1 site in Netherlands.
Trial summary
In a prospective randomized controlled trial, the investigators aim to assess whether external lumbar drainage (ELD) of CSF is safe and reduces delayed cerebral ischemia and its sequelae in patients with an aneurysmal subarachnoid hemorrhage. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Ischemia, Intracranial Vasospasm
- What is being tested?
- external lumbar drainage (ELD) of cerebrospinal fluid
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- Dec 2007to Jun 2009
- Phase
- Phase 2/3
- 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
- spontaneous subarachnoid hemorrhage (SAH) with aneurysmal pattern graded as a Fisher grade III or higher on cerebral CT-scan.
- CSF drainage by external lumbar catheter can start within 96 hours after the initial SAH
- the drainage can start prior to the treatment of the ruptured aneurysm
- informed consent is signed by the patient or his representative
Who cannot join
- spontaneous SAH with aneurysmal pattern graded as a Fisher grade I or II on CT and perimesencephalic hemorrhages
- traumatic SAH
- symptomatic hydrocephalus on admission necessitating drainage (EVD or ELD)
- the presence of a large intraventricular bloodclot in the third or fourth ventricle on CT
- the presence of a mass lesion with significant cerebral midline shift
- all patients whose neurological condition is too poor to allow clinical recognition of signs and symptoms of cerebral vasospasm. This includes all patients with a Hunt and Hess Grade V who failed to improve after initial resuscitation
- no informed consent
- mycotic aneurysms
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevention of Secondary Ischemia After Aneurysmal Subarachnoid Hemorrhage With Cerebrospinal Fluid Drainage. A Randomized Controlled Trial
In a prospective randomized controlled trial, the investigators aim to assess whether external lumbar drainage (ELD) of CSF is safe and reduces delayed cerebral ischemia and its sequelae in patients with an aneurysmal subarachnoid hemorrhage.
Read the detailed description
Delayed cerebral ischemia (DCI) is a frequent complication after an aneurysmal subarachnoid hemorrhage (SAH). Its pathophysiological mechanism remains unclear but a role for cerebral vasospasm and the presence of blood in the arachnoid space is likely. A wash out of blood and blood breakdown products in the cerebrospinal fluid (CSF) could reduce the incidence of vasospasm and DCI.
We aim to assess whether external lumbar drainage (ELD) of CSF is safe and reduces secondary ischemia and its sequelae.
- Conditions
- Brain Ischemia, Intracranial Vasospasm
- Being tested
- external lumbar drainage (ELD) of cerebrospinal fluid
- Keywords
- Subarachnoid hemorrhage, delayed cerebral ischemia, external lumbar drainage, vasospasm
- Medical subject headings
- Brain Ischemia, Vasospasm, Intracranial, Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
external lumbar drainage (ELD) of cerebrospinal fluidProcedure or surgery
Patients were randomized for external lumbar drainage of cerebrospinal fluid or standard treatment of a subarachnoid hemorrhage alone. External drainage was started within 96 hours of initial subarachnoid hemorrhage during 7 days at a maximum of 5-10 ml/hour.
| Study group | Role | What they receive |
|---|---|---|
| external lumbar drainage | Active comparator | Within 96 hours of initial subarachnoid hemorrhage, patients were randomized for external lumbar drainage (ELD)of cerebrospinal fluid during a maximum of 7 days or standard treatment of subarachnoid hemorrhage without ELD Receives: Procedure: external lumbar drainage (ELD) of cerebrospinal fluid |
| No intervention | No intervention | In this arm the patients received standard treatment following protocol for patients with subarachnoid hemorrhage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical signs of delayed cerebral ischemia
DCI was diagnosed when all of the following criteria were met: (1) the onset of new neurological deficits such as confusion, disorientation, drowsiness, or focal deficit during post-hemorrhage days (4 to 14); (2) negative findings on CT obtained to rule out other causes of neurological deterioration such as hemorrhage, cerebral edema, or hydrocephalus. (3) No other identifiable cause of neurological deterioration such as hyponatriemia, hypoxia, drug toxicity, infection, or seizures.
Measured: Patients will be followed for the duration of admission, an expected average of 3 weeks
Secondary outcomes (6)
dichotomized Glasgow outcome score (GOS)
Glasgow outcome scale was measured at discharge
Measured: at discharge, an expected average of 3 weeks after initial bleeding
new ischemic lesions on cerebral CT scan
Measured: at 3 months after initial bleeding
length of stay in intensive care unit
The length of stay in the intensive care unit will be measured.
Measured: Patients will be followed from initial admission until discharge, an expected average of 3 weeks
rebleeding rate of unsecured aneurysms and complications of external lumbar drainage
Evaluation of rebleeding rate of unsecured cerebral aneurysms during external lumbar drainage (ELD) of cerebrospinal fluid and evaluation of (other) complications of ELD such as (local)infection, discomfort/pain.
Measured: Patients willl be followed from initial bleeding until treatment of aneurysm, an expected average of 3 days
dichotomized Glasgow outcome score (GOS
Measured: at 3 months after initial bleeding
clinical signs of delayed cerebral ischemia
As stated in first primary outcome measure 'clinical signs of cerebral ischemia' during admission.
Measured: At 3 months after initial bleeding
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2011 (estimated)
- Study startDec 2007
- Primary completionMar 2009
- Study completionJun 2009
Why it stopped: patient enrollment too slow
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain IschemiaStudies 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elisabeth-TweeSteden Ziekenhuis
- Sponsor type
- University, hospital or other
- Investigators
- Paul Depauw, MD, Principal investigator, Elisabeth-TweeSteden Ziekenhuis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01407614
- Sponsor's protocol ID
- 15378
- Status last verified
- Aug 2011
- First submitted
- 10 Jan 2011
- Last updated
- 2 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Secondary Ischemia After Aneurysmal Subarachnoid Hemorrhage With Cerebrospinal Fluid Drainage. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01407614
- Acronym / sponsor ID
- 15378
- Conditions
- Brain Ischemia, Intracranial Vasospasm
- Keywords
- Subarachnoid hemorrhage, delayed cerebral ischemia, external lumbar drainage, vasospasm
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: patient enrollment too slow
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Elisabeth-TweeSteden ZiekenhuisUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- Mar 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 2 Aug 2011 (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.
In a prospective randomized controlled trial, the investigators aim to assess whether external lumbar drainage (ELD) of CSF is safe and reduces delayed cerebral ischemia and its sequelae in patients with an aneurysmal subarachnoid hemorrhage.
Detailed description
Delayed cerebral ischemia (DCI) is a frequent complication after an aneurysmal subarachnoid hemorrhage (SAH). Its pathophysiological mechanism remains unclear but a role for cerebral vasospasm and the presence of blood in the arachnoid space is likely. A wash out of blood and blood breakdown products in the cerebrospinal fluid (CSF) could reduce the incidence of vasospasm and DCI.
We aim to assess whether external lumbar drainage (ELD) of CSF is safe and reduces secondary ischemia and its sequelae.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| external lumbar drainage | Active comparator | Procedure: external lumbar drainage (ELD) of cerebrospinal fluidWithin 96 hours of initial subarachnoid hemorrhage, patients were randomized for external lumbar drainage (ELD)of cerebrospinal fluid during a maximum of 7 days or standard treatment of subarachnoid hemorrhage without ELD |
| No intervention | No intervention | –In this arm the patients received standard treatment following protocol for patients with subarachnoid hemorrhage |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- spontaneous subarachnoid hemorrhage (SAH) with aneurysmal pattern graded as a Fisher grade III or higher on cerebral CT-scan.
- CSF drainage by external lumbar catheter can start within 96 hours after the initial SAH
- the drainage can start prior to the treatment of the ruptured aneurysm
- informed consent is signed by the patient or his representative
Key exclusion criteria (8 listed)
- spontaneous SAH with aneurysmal pattern graded as a Fisher grade I or II on CT and perimesencephalic hemorrhages
- traumatic SAH
- symptomatic hydrocephalus on admission necessitating drainage (EVD or ELD)
- the presence of a large intraventricular bloodclot in the third or fourth ventricle on CT
- the presence of a mass lesion with significant cerebral midline shift
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 |
|---|---|---|
| external lumbar drainage (ELD) of cerebrospinal fluidPatients were randomized for external lumbar drainage of cerebrospinal fluid or standard treatment of a subarachnoid hemorrhage alone. External drainage was started within 96 hours of initial subarachnoid hemorrhage during 7 days at a maximum of 5-10 ml/hour. | Procedure or surgery | external lumbar drainage |
Primary outcome
Clinical signs of delayed cerebral ischemia
Time frame: Patients will be followed for the duration of admission, an expected average of 3 weeks
DCI was diagnosed when all of the following criteria were met: (1) the onset of new neurological deficits such as confusion, disorientation, drowsiness, or focal deficit during post-hemorrhage days (4 to 14); (2) negative findings on CT obtained to rule out other causes of neurological deterioration such as hemorrhage, cerebral edema, or hydrocephalus. (3) No other identifiable cause of neurological deterioration such as hyponatriemia, hypoxia, drug toxicity, infection, or seizures.
6 secondary outcomes
dichotomized Glasgow outcome score (GOS)
Time frame: at discharge, an expected average of 3 weeks after initial bleeding
new ischemic lesions on cerebral CT scan
Time frame: at 3 months after initial bleeding
length of stay in intensive care unit
Time frame: Patients will be followed from initial admission until discharge, an expected average of 3 weeks
rebleeding rate of unsecured aneurysms and complications of external lumbar drainage
Time frame: Patients willl be followed from initial bleeding until treatment of aneurysm, an expected average of 3 days
dichotomized Glasgow outcome score (GOS
Time frame: at 3 months after initial bleeding
clinical signs of delayed cerebral ischemia
Time frame: At 3 months after initial bleeding
Results and safety
The study was stopped early (reason given: patient enrollment too slow). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2011.
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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.
Paul Depauw, MD principal investigator
Elisabeth-TweeSteden Ziekenhuis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing external lumbar drainage (ELD) of cerebrospinal fluid in people with Brain Ischemia and Intracranial Vasospasm, run by Elisabeth-TweeSteden Ziekenhuis at 1 site in Netherlands.
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 4 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: stopped early, as of the sponsor's last update on 2 Aug 2011. 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 Netherlands. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early (reason given: patient enrollment too slow). Results are not available in the source record.
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?
Clinical signs of delayed cerebral ischemia (time frame: Patients will be followed for the duration of admission, an expected average of 3 weeks). 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 2 Aug 2011.