NCT00930072

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Apr 2009

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 26, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 30, 2009

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

September 27, 2017

Status Verified

September 1, 2017

Enrollment Period

5.7 years

First QC Date

June 26, 2009

Last Update Submit

September 25, 2017

Conditions

Vasospasm

Outcome Measures

Primary Outcomes (1)

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

    3 months

Study Arms (2)

Block

EXPERIMENTAL
Drug: Cervical Sympathetic Block (bupivicaine, clonidine)

Standard Care

NO INTERVENTION

Interventions

Cervical Sympathetic Block (bupivicaine, clonidine)DRUG

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

Also known as: Bupivicaine, Clonidine
Block

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

MeSH Terms

Interventions

Clonidine

Intervention Hierarchy (Ancestors)

ImidazolinesImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Miriam Treggiari, MD

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 26, 2009

First Posted

June 30, 2009

Study Start

April 1, 2009

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

September 27, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)