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

This study is currently recruiting participants.

Verified April 2011 by University of Washington

First Received on June 26, 2009. Last Updated on April 20, 2011 History of Changes

Sponsor:	University of Washington
Information provided by:	University of Washington
ClinicalTrials.gov Identifier:	NCT00930072

Purpose

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

Condition	Intervention	Phase
Severe Vasospasm	Drug: Cervical Sympathetic Block (bupivicaine, clonidine)	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Caregiver, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Safety and Efficacy of Cervical Sympathetic Block in Patients With Cerebral Vasospasm Following Aneurysmal Subarachnoid Hemorrhage - Pilot Study

Resource links provided by NLM:

Drug Information available for: Bupivacaine hydrochloride Bupivacaine Clonidine Clonidine hydrochloride

U.S. FDA Resources

Further study details as provided by University of Washington:

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. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	April 2009
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Block	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. Other Names: Bupivicaine Clonidine
No Intervention: Standard Care

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00930072

Contacts

Contact: Miriam Treggiari, MD	206-744-4687	treggmm@u.washington.edu
Contact: Laura Sissons-Ross	206-744-5992	lsissons@uw.edu

Locations

United States, Washington
Harborview Medical Center	Recruiting
Seattle, Washington, United States, 98104

Sponsors and Collaborators

University of Washington

Investigators

Principal Investigator:

Miriam Treggiari, MD

University of Washington

More Information

No publications provided

Responsible Party:	Miriam Treggiari, Associate Professor of Anesthesiology & Pain Medicine, University of Washington
ClinicalTrials.gov Identifier:	NCT00930072 History of Changes
Other Study ID Numbers:	34225-D
Study First Received:	June 26, 2009
Last Updated:	April 20, 2011
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Hemorrhage
Subarachnoid Hemorrhage
Vasospasm, Intracranial
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Bupivacaine
Clonidine
Anesthetics, Local
Anesthetics

Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Antihypertensive Agents
Cardiovascular Agents
Sympatholytics
Autonomic Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents

ClinicalTrials.gov processed this record on February 09, 2012