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

This study has been terminated.
(Poor Enrollment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00930072
First Posted: June 30, 2009
Last Update Posted: September 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Miriam Treggiari, University of Washington
  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
Vasospasm Drug: Cervical Sympathetic Block (bupivicaine, clonidine) Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, 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:


Further study details as provided by Miriam Treggiari, 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 ]

Enrollment: 7
Study Start Date: April 2009
Study Completion Date: December 2014
Primary Completion Date: December 2014 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00930072


Locations
United States, Washington
Harborview Medical Center
Seattle, Washington, United States, 98104
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: Miriam Treggiari, MD University of Washington
  More Information

Responsible Party: Miriam Treggiari, Professor, University of Washington
ClinicalTrials.gov Identifier: NCT00930072     History of Changes
Other Study ID Numbers: 34225
First Submitted: June 26, 2009
First Posted: June 30, 2009
Last Update Posted: September 27, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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
Sensory System Agents
Peripheral Nervous System Agents
Analgesics
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action