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Anticoagulation in Blunt Cerebrovascular Injuries

Primary Purpose

Carotid Artery Injury, Vertebral Artery Injury

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
heparin
aspirin and clopidogrel
Sponsored by
C. Clay Cothren, MD
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Carotid Artery Injury

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients greater than 18 years old with documented grade I-III blunt cerebrovascular injuries.

Exclusion Criteria:

  • Pregnancy
  • Nasal polyps
  • Previous gastrointestinal bleeding secondary to antiplatelet medications
  • Contraindication to systemic anticoagulation.

Sites / Locations

  • Denver Health Medical Center

Outcomes

Primary Outcome Measures

Neurologic sequelae

Secondary Outcome Measures

Full Information

First Posted
June 25, 2007
Last Updated
October 20, 2015
Sponsor
C. Clay Cothren, MD
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1. Study Identification

Unique Protocol Identification Number
NCT00494156
Brief Title
Anticoagulation in Blunt Cerebrovascular Injuries
Official Title
Anticoagulation in the Management of Grade I-III Blunt Cerebrovascular Injuries
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Withdrawn
Why Stopped
Study halted prematurely prior to enrollment of first participant.
Study Start Date
July 2003 (undefined)
Primary Completion Date
July 2008 (Anticipated)
Study Completion Date
July 2008 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
C. Clay Cothren, MD

4. Oversight

5. Study Description

Brief Summary
Originally thought to be a rare occurrence, BCVI are now diagnosed in approximately 1% of blunt trauma patients. Initially BCVI were thought to have unavoidable devastating neurologic outcomes. But early reports suggested anticoagulation might decrease these events. If untreated, carotid artery injuries (CAI) have a stoke rate up to 50% depending on injury grade, with increasing stroke rates correlating with increasing grades of injury. Current studies report early treatment with antithrombotics - either heparin or anti-platelet agents - in patients with BCVI markedly reduces stroke rates and resultant neurologic morbidity. As reports of bleeding complications have altered heparin protocols in these patients, the use of antiplatelet agents is attractive. Although heparin has been has been proposed as the gold standard treatment due to its initial empiric use, no comparative studies of antithrombotic agents has been performed. In sum, Grade I-III blunt carotid and vertebral arterial injuries (BCVI) have the potential for stroke, and should be treated. Heparin has not been shown to clearly improve healing rates compared with antiplatelet therapy. The purpose of this study is to determine whether systemic anticoagulation alters the course of Grade I-III BCVI compared with antiplatelet therapy. The investigators study hypothesis is that Grade I-III BCVI will heal or progress to pseudoaneurysm formation, independent of systemic antithrombotic regimen, and that the combination of aspirin and clopidogrel is equally efficacious in preventing neurologic symptoms compared to systemic heparin associated with Grade I-III BCVI.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carotid Artery Injury, Vertebral Artery Injury

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
heparin
Intervention Type
Drug
Intervention Name(s)
aspirin and clopidogrel
Primary Outcome Measure Information:
Title
Neurologic sequelae
Time Frame
during hospital visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients greater than 18 years old with documented grade I-III blunt cerebrovascular injuries. Exclusion Criteria: Pregnancy Nasal polyps Previous gastrointestinal bleeding secondary to antiplatelet medications Contraindication to systemic anticoagulation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clay Cothren, MD
Organizational Affiliation
Denver Health Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Denver Health Medical Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204
Country
United States

12. IPD Sharing Statement

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Anticoagulation in Blunt Cerebrovascular Injuries

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