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

NCT ID: NCT00930072

Last Updated: 2017-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2014-12-31

Brief Summary

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

Detailed Description

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Conditions

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Vasospasm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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Block

Group Type EXPERIMENTAL

Cervical Sympathetic Block (bupivicaine, clonidine)

Intervention Type DRUG

12-15ml solution of bupivicaine .5% containing 50 mcg of clonidine for cervical sympathetic block administered in a single injection.

Standard Care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Bupivicaine Clonidine

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Washington

OTHER

Sponsor Role lead

Responsible Party

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Miriam Treggiari

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Miriam Treggiari, MD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

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Harborview Medical Center

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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34225

Identifier Type: -

Identifier Source: org_study_id