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

University of Washington

Status and phase: Terminated; Phase 2

Conditions: Vasospasm

Treatments: Drug: Cervical Sympathetic Block (bupivicaine, clonidine)

Study type: Interventional

Funder types: Other

Identifiers

NCT00930072

34225

Details and patient eligibility

About

To evaluate the feasibility of performing a cervical sympathetic block in patients with severe cerebral vasospasm involving the anterior cerebral circulation following aneurysmal SAH.

Enrollment: 7 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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7 participants in 2 patient groups

Block

Experimental group

Treatment:

Drug: Cervical Sympathetic Block (bupivicaine, clonidine)

Standard Care

No Intervention group