Lumbar Drain vs Extraventricular Drain to Prevent Vasospasm in Subarachnoid Hemorrhage
| Status: | Recruiting |
|---|---|
| Conditions: | Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 18 - 110 |
| Updated: | 10/19/2018 |
| Start Date: | January 1, 2017 |
| End Date: | January 1, 2023 |
Lumbar Drainage Compared With Extraventricular Drainage of Cerebral Spinal Fluid in Treatment of Patients With Subarachnoid Hemorrhage - a Prospective Randomized Controlled Trial
Vasospasm is a common complication after rupture of intracranial aneurysms causing
devastating neurologic deficits and death. Vasospasm has been directly associated with the
amount of subarachnoid blood inside the basal cisterns. Prior literature has attempted to
refine treatment of ruptured intracranial aneurysms but does not have clear guidelines on the
optimal method to drain subarachnoid blood. Two methods, extraventricular drain (EVD) and
lumbar drain (LD) have been compared retrospectively yet remain controversial as to which
method is optimal in reducing subarachnoid blood and preventing vasospasm. This study would
be a prospective randomized trial in which patients would be assigned to EVD or LD and
observed to see if one method of intervention is associated with preventing clinical
vasospasm, decreasing subarachnoid blood, shortening overall ICU stay, and reducing the need
for a permanent ventriculoperitoneal shunt. The conclusions of this study may identify an
optimal treatment modality to benefit all future patients with ruptured intracranial
aneurysms.
devastating neurologic deficits and death. Vasospasm has been directly associated with the
amount of subarachnoid blood inside the basal cisterns. Prior literature has attempted to
refine treatment of ruptured intracranial aneurysms but does not have clear guidelines on the
optimal method to drain subarachnoid blood. Two methods, extraventricular drain (EVD) and
lumbar drain (LD) have been compared retrospectively yet remain controversial as to which
method is optimal in reducing subarachnoid blood and preventing vasospasm. This study would
be a prospective randomized trial in which patients would be assigned to EVD or LD and
observed to see if one method of intervention is associated with preventing clinical
vasospasm, decreasing subarachnoid blood, shortening overall ICU stay, and reducing the need
for a permanent ventriculoperitoneal shunt. The conclusions of this study may identify an
optimal treatment modality to benefit all future patients with ruptured intracranial
aneurysms.
This study will be a prospective randomized controlled trial. Participants will be patients
admitted at UCSD Hillcrest or Thornton Hospital for subarachnoid hemorrhage. Patients will be
recruited by the Endovascular Neurosurgical treatment team. Since there are no existing
guidelines existing for procedural drainage of subarachnoid blood from the intracranial
cisterns, patients are currently treated with either lumbar drain or extraventricular drain.
This study would randomize the process of assigning patients to either LD or EVD as part of
their treatment package for subarachnoid hemorrhage.
Both EVD and LD are regularly performed at UCSD. Both procedures are equally likely to take
place if patients do not have randomization. There is currently no gold standard that
dictates whether EVD should be done over LD and vice versa.
Patients will be consented to partake in the study while they are also consented for their
usual care in SAH. Briefly, inclusion criteria are patients with Fisher Grade II, III, IV SAH
or any aneurysmal SAH patients with radiographic evidence of hydrocephalus. Briefly,
exclusion criteria are patients with obstructive hydrocephalus or mass lesion that would
preclude lumbar drain placement. Pregnant patients or minors of age <18 will not be included
in this study.
There will be two arms of the study: patients randomly assigned to LD and patients randomly
assigned to EVD. Randomization will account for Fisher Grade. The two treatment arms will
have CSF diversion for 7 days. For patients treated with lumbar drain, patients will have CSF
drainage of 10cc/hour for lumbar drain while patients treated with EVD at 15cm above the
tragus.
Both an extraventricular drain and a lumbar drain are defined as significant risk devices
however both devices are FDA approved and will be utilized in the exact manner that they are
intended. Both devices are already regularly utilized and a part of the standard of care for
sub arachnoid hemorrhage management and will not be utilized in any novel way. LD and EVD
assignment will be randomized through the protocol of the study.
Data will be collected via electronic medical record and will assess patient age, patient
presenting Hess grade and clinical improvement post cerebrospinal fluid diversion, aneurysmal
bleed day on presentation, method and technical success of securing aneurysm (clip versus
coil), size and location of aneurysm, discharge disposition and clinical exam (NIH Stroke
Scale), complications (tract hemorrhage or infection), need for intra-arterial management of
vasospasm.
Expected Sample size in this study will include approximately 200 patients in which half of
patients included in this study will be treated with LD and the other half treated with EVD.
The number of estimated patients is calculated from the annual incidence of SAH received at
UCSD hospitals. The facilities that are available for this project include UCSD Hillcrest
Hospital, UCSD Thornton Hospital, and the UCSD Endovascular Neurosurgery suite.
The primary outcome of this study will be time to clearance of acute cisternal blood by
surveillance CT (stratified by presenting Fischer Grade), need for endovascular treatment of
vasospasm or stroke from vasospasm, time spent in the critical care unit, and need for
ventriculoperitoneal shunt.
Regarding CT scans; Surveillance CTs are standard of care. They are typically performed on
the day of device placement and subsequent imaging takes place pending clinical resolution of
the patient. For most patients, they have an additional CT scan 1-2 days after initial device
placement and a final scan on the 7th day of device placement. If clinical condition
deteriorates, patients will have an additional scan to monitor for intracranial bleeding. The
scans are performed for the clinical purpose of monitoring resolution of intracranial injury.
This study would collect the data obtained from the scans.
The total exposure resulting from these imaging studies is calculated to be approximately 10
mSv. Additional head CT may be performed if clinically indicated with exposure 2.5 mSv per
scan. Fluoroscopy is not routinely used, however if clinically indicated, may be utilized
during lumbar drainage procedure with radiation exposure 1.5 mSv per minute. This amount is
more than one would receive from one year of natural exposure in the San Diego area, which is
approximately 1.6 mSv. Cumulative exposure from radiation may increase a person's risk of
developing certain types of cancer in the future. This imaging is determined to be part of
routine care and management of SAH. In this study, we will be merely collecting data from
these images to determine clinical incidence of vasospasm and resolution of cisternal
bleeding.
DSM criteria were derived from Al Tamimi et al. The initial power calculation was based off
of the Al Tamimi et at study 9 that demonstrated that for 85% power, 105 patients were
required in each arm of the trial. Interim analysis will be performed after recruiting 40
patients in order to establish adverse effects and an additional reevaluation at 100 patients
to determine if one arm of the study is superior to the other. If this is identified, the
trial will be stopped at recruitment of 100 patients. Statistical analysis will continue
throughout the trial. If statistically significant differences between both arms of the study
are identified earlier in the enrollment process, the study will be discontinued. Monitoring
will take place internally in which the differences between the two groups will be examined
for each additional 5 patients added to both groups. Internal monitoring will take place by
(D.R.S.D., A.W., R.R., A.K., S.P.)
Statistical methods to evaluate data include chi square test, using independent t tests for
normal numerical data, and comparing categorical data with Fisher exact test. P value of .05
will be considered clinically significant in this study.
admitted at UCSD Hillcrest or Thornton Hospital for subarachnoid hemorrhage. Patients will be
recruited by the Endovascular Neurosurgical treatment team. Since there are no existing
guidelines existing for procedural drainage of subarachnoid blood from the intracranial
cisterns, patients are currently treated with either lumbar drain or extraventricular drain.
This study would randomize the process of assigning patients to either LD or EVD as part of
their treatment package for subarachnoid hemorrhage.
Both EVD and LD are regularly performed at UCSD. Both procedures are equally likely to take
place if patients do not have randomization. There is currently no gold standard that
dictates whether EVD should be done over LD and vice versa.
Patients will be consented to partake in the study while they are also consented for their
usual care in SAH. Briefly, inclusion criteria are patients with Fisher Grade II, III, IV SAH
or any aneurysmal SAH patients with radiographic evidence of hydrocephalus. Briefly,
exclusion criteria are patients with obstructive hydrocephalus or mass lesion that would
preclude lumbar drain placement. Pregnant patients or minors of age <18 will not be included
in this study.
There will be two arms of the study: patients randomly assigned to LD and patients randomly
assigned to EVD. Randomization will account for Fisher Grade. The two treatment arms will
have CSF diversion for 7 days. For patients treated with lumbar drain, patients will have CSF
drainage of 10cc/hour for lumbar drain while patients treated with EVD at 15cm above the
tragus.
Both an extraventricular drain and a lumbar drain are defined as significant risk devices
however both devices are FDA approved and will be utilized in the exact manner that they are
intended. Both devices are already regularly utilized and a part of the standard of care for
sub arachnoid hemorrhage management and will not be utilized in any novel way. LD and EVD
assignment will be randomized through the protocol of the study.
Data will be collected via electronic medical record and will assess patient age, patient
presenting Hess grade and clinical improvement post cerebrospinal fluid diversion, aneurysmal
bleed day on presentation, method and technical success of securing aneurysm (clip versus
coil), size and location of aneurysm, discharge disposition and clinical exam (NIH Stroke
Scale), complications (tract hemorrhage or infection), need for intra-arterial management of
vasospasm.
Expected Sample size in this study will include approximately 200 patients in which half of
patients included in this study will be treated with LD and the other half treated with EVD.
The number of estimated patients is calculated from the annual incidence of SAH received at
UCSD hospitals. The facilities that are available for this project include UCSD Hillcrest
Hospital, UCSD Thornton Hospital, and the UCSD Endovascular Neurosurgery suite.
The primary outcome of this study will be time to clearance of acute cisternal blood by
surveillance CT (stratified by presenting Fischer Grade), need for endovascular treatment of
vasospasm or stroke from vasospasm, time spent in the critical care unit, and need for
ventriculoperitoneal shunt.
Regarding CT scans; Surveillance CTs are standard of care. They are typically performed on
the day of device placement and subsequent imaging takes place pending clinical resolution of
the patient. For most patients, they have an additional CT scan 1-2 days after initial device
placement and a final scan on the 7th day of device placement. If clinical condition
deteriorates, patients will have an additional scan to monitor for intracranial bleeding. The
scans are performed for the clinical purpose of monitoring resolution of intracranial injury.
This study would collect the data obtained from the scans.
The total exposure resulting from these imaging studies is calculated to be approximately 10
mSv. Additional head CT may be performed if clinically indicated with exposure 2.5 mSv per
scan. Fluoroscopy is not routinely used, however if clinically indicated, may be utilized
during lumbar drainage procedure with radiation exposure 1.5 mSv per minute. This amount is
more than one would receive from one year of natural exposure in the San Diego area, which is
approximately 1.6 mSv. Cumulative exposure from radiation may increase a person's risk of
developing certain types of cancer in the future. This imaging is determined to be part of
routine care and management of SAH. In this study, we will be merely collecting data from
these images to determine clinical incidence of vasospasm and resolution of cisternal
bleeding.
DSM criteria were derived from Al Tamimi et al. The initial power calculation was based off
of the Al Tamimi et at study 9 that demonstrated that for 85% power, 105 patients were
required in each arm of the trial. Interim analysis will be performed after recruiting 40
patients in order to establish adverse effects and an additional reevaluation at 100 patients
to determine if one arm of the study is superior to the other. If this is identified, the
trial will be stopped at recruitment of 100 patients. Statistical analysis will continue
throughout the trial. If statistically significant differences between both arms of the study
are identified earlier in the enrollment process, the study will be discontinued. Monitoring
will take place internally in which the differences between the two groups will be examined
for each additional 5 patients added to both groups. Internal monitoring will take place by
(D.R.S.D., A.W., R.R., A.K., S.P.)
Statistical methods to evaluate data include chi square test, using independent t tests for
normal numerical data, and comparing categorical data with Fisher exact test. P value of .05
will be considered clinically significant in this study.
Inclusion Criteria:
- patients received at the UCSD Medical Center with grade II, III, IV subarachnoid
hemorrhage or patients with aneurysmal SAH with radiographic evidence.
Exclusion Criteria:
- patients under the age of 18, excluding minors from this study
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