Safety Study of Cervical Sympathetic Block for Cerebral Vasospasm Following Aneurysmal Subarachnoid Hemorrhage

Vasospasm Clinical Trial

Official title:

Safety and Efficacy of Cervical Sympathetic Block in Patients With Cerebral Vasospasm Following Aneurysmal Subarachnoid Hemorrhage - Pilot Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00930072
• Other study ID #: 34225
• Status: Terminated
• Phase: Phase 2
• First received: June 26, 2009
• Last updated: September 25, 2017
• Start date: April 2009
• Est. completion date: December 2014

Study information

• Verified date: September 2017
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage
• Subarachnoid Hemorrhage
• Vasospasm
• Vasospasm, Intracranial

Intervention

Drug:
• Cervical Sympathetic Block (bupivicaine, clonidine)
12-15ml solution of bupivicaine .5% containing 50 mcg of clonidine for cervical sympathetic block administered in a single injection.

Locations

Country	Name	City	State
United States	Harborview Medical Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the feasibility of performing a cervical sympathetic block in patients with severe cerebral vasospasm involving the anterior cerebral circulation following aneurysmal SAH.		3 months