Back to resultsThe Tilburg Vasospasm Study
Primary Purpose
Brain Ischemia, Intracranial Vasospasm
Status
Terminated
Phase
Phase 2
Locations
Netherlands
Study Type
Interventional
Intervention
external lumbar drainage (ELD) of cerebrospinal fluid
Sponsored by
About this trial
This is an interventional prevention trial for Brain Ischemia focused on measuring Subarachnoid hemorrhage, delayed cerebral ischemia, external lumbar drainage, vasospasm
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- St Elisabeth Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
external lumbar drainage
No intervention
Arm Description
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
In this arm the patients received standard treatment following protocol for patients with subarachnoid hemorrhage
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
dichotomized Glasgow outcome score (GOS)
Glasgow outcome scale was measured at discharge
new ischemic lesions on cerebral CT scan
length of stay in intensive care unit
The length of stay in the intensive care unit will be measured.
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.
dichotomized Glasgow outcome score (GOS
clinical signs of delayed cerebral ischemia
As stated in first primary outcome measure 'clinical signs of cerebral ischemia' during admission.
Full Information
NCT ID
NCT01407614
First Posted
January 10, 2011
Last Updated
August 1, 2011
Sponsor
Elisabeth-TweeSteden Ziekenhuis
1. Study Identification
Unique Protocol Identification Number
NCT01407614
Brief Title
The Tilburg Vasospasm Study
Official Title
Prevention of Secondary Ischemia After Aneurysmal Subarachnoid Hemorrhage With Cerebrospinal Fluid Drainage. A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2011
Overall Recruitment Status
Terminated
Why Stopped
patient enrollment too slow
Study Start Date
December 2007 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
June 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Elisabeth-TweeSteden Ziekenhuis
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Ischemia, Intracranial Vasospasm
Keywords
Subarachnoid hemorrhage, delayed cerebral ischemia, external lumbar drainage, vasospasm
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
external lumbar drainage
Arm Type
Active Comparator
Arm Description
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
Arm Title
No intervention
Arm Type
No Intervention
Arm Description
In this arm the patients received standard treatment following protocol for patients with subarachnoid hemorrhage
Intervention Type
Procedure
Intervention Name(s)
external lumbar drainage (ELD) of cerebrospinal fluid
Intervention Description
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.
Primary Outcome Measure Information:
Title
Clinical signs of delayed cerebral ischemia
Description
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.
Time Frame
Patients will be followed for the duration of admission, an expected average of 3 weeks
Secondary Outcome Measure Information:
Title
dichotomized Glasgow outcome score (GOS)
Description
Glasgow outcome scale was measured at discharge
Time Frame
at discharge, an expected average of 3 weeks after initial bleeding
Title
new ischemic lesions on cerebral CT scan
Time Frame
at 3 months after initial bleeding
Title
length of stay in intensive care unit
Description
The length of stay in the intensive care unit will be measured.
Time Frame
Patients will be followed from initial admission until discharge, an expected average of 3 weeks
Title
rebleeding rate of unsecured aneurysms and complications of external lumbar drainage
Description
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.
Time Frame
Patients willl be followed from initial bleeding until treatment of aneurysm, an expected average of 3 days
Title
dichotomized Glasgow outcome score (GOS
Time Frame
at 3 months after initial bleeding
Title
clinical signs of delayed cerebral ischemia
Description
As stated in first primary outcome measure 'clinical signs of cerebral ischemia' during admission.
Time Frame
At 3 months after initial bleeding
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Depauw, MD
Organizational Affiliation
Elisabeth-TweeSteden Ziekenhuis
Official's Role
Principal Investigator
Facility Information:
Facility Name
St Elisabeth Hospital
City
Tilburg
State/Province
Brabant
ZIP/Postal Code
5022 GC
Country
Netherlands
12. IPD Sharing Statement
Learn more about this trial
The Tilburg Vasospasm Study
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