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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by University of Washington
Sponsor:
Information provided by (Responsible Party):
Miriam Treggiari, University of Washington
ClinicalTrials.gov Identifier:
NCT00930072
First received: June 26, 2009
Last updated: June 18, 2013
Last verified: June 2013
  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 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:


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 2014
Estimated 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, Professor, University of Washington
ClinicalTrials.gov Identifier: NCT00930072     History of Changes
Other Study ID Numbers: 34225-D
Study First Received: June 26, 2009
Last Updated: June 18, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hemorrhage
Subarachnoid Hemorrhage
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
Analgesics
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 September 18, 2014