Safety Study of Cervical Sympathetic Block for Cerebral Vasospasm Following Aneurysmal Subarachnoid Hemorrhage
Primary Purpose
Vasospasm
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Cervical Sympathetic Block (bupivicaine, clonidine)
Sponsored by
About this trial
This is an interventional treatment trial for Vasospasm
Eligibility Criteria
Inclusion Criteria:
- High grade spontaneous SAH (Fisher Grade III and IV)
- Secured aneurysm (clipped/coiled)
- Evidence of severe vasospasm - MCA mean flow velocity >200 cm/sec and Lindegaard ratio >6 OR Symptomatic vasospasm with either angiographic evidence (no angioplasty), or at least moderate severity according to TCD criteria (MCA mean flow velocity >150 cm/sec and Lindegaard ratio >3, or ACA vasospasm)
- Age ≥18
Exclusion Criteria:
- Allergy to local anesthetic or contrast
- Coagulation disorders with PT <70%, or INR >1.4, or PTT >1.5 times control and/or platelets <70,000x106/L
- Use of enoxaparin within 12 hours
- Use of clopidogrel within 7 days
- Use of coumadin within 5 days
- Use of ticlopidine within 14 days
- Use of intravenous thrombolytics within 10 days
- Any use of hirudin derivatives during ICU stay
Sites / Locations
- Harborview Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Block
Standard Care
Arm Description
Outcomes
Primary Outcome Measures
To evaluate the feasibility of performing a cervical sympathetic block in patients with severe cerebral vasospasm involving the anterior cerebral circulation following aneurysmal SAH.
Secondary Outcome Measures
Full Information
NCT ID
NCT00930072
First Posted
June 26, 2009
Last Updated
September 25, 2017
Sponsor
University of Washington
1. Study Identification
Unique Protocol Identification Number
NCT00930072
Brief Title
Safety Study of Cervical Sympathetic Block for Cerebral Vasospasm Following Aneurysmal Subarachnoid Hemorrhage
Official Title
Safety and Efficacy of Cervical Sympathetic Block in Patients With Cerebral Vasospasm Following Aneurysmal Subarachnoid Hemorrhage - Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Terminated
Why Stopped
Poor Enrollment
Study Start Date
April 2009 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To evaluate the feasibility of performing a cervical sympathetic block in patients with severe cerebral vasospasm involving the anterior cerebral circulation following aneurysmal SAH.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vasospasm
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Block
Arm Type
Experimental
Arm Title
Standard Care
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Cervical Sympathetic Block (bupivicaine, clonidine)
Other Intervention Name(s)
Bupivicaine, Clonidine
Intervention Description
12-15ml solution of bupivicaine .5% containing 50 mcg of clonidine for cervical sympathetic block administered in a single injection.
Primary Outcome Measure Information:
Title
To evaluate the feasibility of performing a cervical sympathetic block in patients with severe cerebral vasospasm involving the anterior cerebral circulation following aneurysmal SAH.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
High grade spontaneous SAH (Fisher Grade III and IV)
Secured aneurysm (clipped/coiled)
Evidence of severe vasospasm - MCA mean flow velocity >200 cm/sec and Lindegaard ratio >6 OR Symptomatic vasospasm with either angiographic evidence (no angioplasty), or at least moderate severity according to TCD criteria (MCA mean flow velocity >150 cm/sec and Lindegaard ratio >3, or ACA vasospasm)
Age ≥18
Exclusion Criteria:
Allergy to local anesthetic or contrast
Coagulation disorders with PT <70%, or INR >1.4, or PTT >1.5 times control and/or platelets <70,000x106/L
Use of enoxaparin within 12 hours
Use of clopidogrel within 7 days
Use of coumadin within 5 days
Use of ticlopidine within 14 days
Use of intravenous thrombolytics within 10 days
Any use of hirudin derivatives during ICU stay
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miriam Treggiari, MD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
Harborview Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Safety Study of Cervical Sympathetic Block for Cerebral Vasospasm Following Aneurysmal Subarachnoid Hemorrhage
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