Safety and Efficacy of Cervical Sympathetic Block in Patients With Cerebral Vasospasm Following Aneurysmal Subarachnoid Hemorrhage - Pilot Study
Information source: University of Washington
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Severe Vasospasm
Intervention: Cervical Sympathetic Block (bupivicaine, clonidine) (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: University of Washington Official(s) and/or principal investigator(s):
Miriam Treggiari, MD, Principal Investigator, Affiliation: University of Washington
Overall contact:
Miriam Treggiari, MD, Phone: 206-744-4687, Email: treggmm@u.washington.edu
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.
Clinical Details
Official title: Safety and Efficacy of Cervical Sympathetic Block in Patients With Cerebral Vasospasm Following Aneurysmal Subarachnoid Hemorrhage - Pilot Study
Study design: Treatment, Randomized, Double Blind (Caregiver, Outcomes Assessor), Parallel Assignment
Primary outcome: To evaluate the feasibility of performing a cervical sympathetic block in patients with severe cerebral vasospasm involving the anterior cerebral circulation following aneurysmal SAH.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. High grade spontaneous SAH (Fisher Grade III and IV)
2. Secured aneurysm (clipped/coiled)
3. 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)
4. Age ≥18
Exclusion Criteria:
1. Allergy to local anesthetic or contrast
2. Coagulation disorders with PT <70%, or INR >1. 4, or PTT >1. 5 times control and/or
platelets <70,000x106/L
3. Use of enoxaparin within 12 hours
4. Use of clopidogrel within 7 days
5. Use of coumadin within 5 days
6. Use of ticlopidine within 14 days
7. Use of intravenous thrombolytics within 10 days
8. Any use of hirudin derivatives during ICU stay
Locations and Contacts
Miriam Treggiari, MD, Phone: 206-744-4687, Email: treggmm@u.washington.edu
Harborview Medical Center, Seattle, Washington 98104, United States; Recruiting
Additional Information
Starting date: April 2009
Ending date: July 2010
Last updated: June 29, 2009
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