Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Anticoagulation in Blunt Cerebrovascular Injuries
This study is currently recruiting participants.
Verified by Denver Health Medical Center, May 2008
Sponsored by: Denver Health Medical Center
Information provided by: Denver Health Medical Center
ClinicalTrials.gov Identifier: NCT00494156
  Purpose

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. Our 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.


Condition Intervention
Carotid Artery Injury
Vertebral Artery Injury
Drug: heparin
Drug: aspirin and clopidogrel

MedlinePlus related topics: Blood Thinners
Drug Information available for: Heparin Acetylsalicylic acid Clopidogrel Clopidogrel Bisulfate
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment
Official Title: Anticoagulation in the Management of Grade I-III Blunt Cerebrovascular Injuries

Further study details as provided by Denver Health Medical Center:

Primary Outcome Measures:
  • Neurologic sequelae [ Time Frame: In-hospital ]

Study Start Date: July 2003
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00494156

Contacts
Contact: Clay Cothren, MD 303-436-6558 clay.cothren@dhha.org
Contact: Ernest E Moore, MD 303-436-6558 ernest.moore@dhha.org

Locations
United States, Colorado
Denver Health Medical Center Recruiting
Denver, Colorado, United States, 80204
Contact: Clay Cothren, MD     303-436-6558     clay.cothren@dhha.org    
Sponsors and Collaborators
Denver Health Medical Center
Investigators
Principal Investigator: Clay Cothren, MD Denver Health Medical Center
  More Information

Study ID Numbers: COMIRB 00-508
Study First Received: June 25, 2007
Last Updated: May 6, 2008
ClinicalTrials.gov Identifier: NCT00494156  
Health Authority: United States: Institutional Review Board

Study placed in the following topic categories:
Carotid Artery Injuries
Wounds and Injuries
Vascular Diseases
Central Nervous System Diseases
Disorders of Environmental Origin
Trauma, Nervous System
Brain Diseases
Cerebrovascular Disorders
Calcium heparin
Aspirin
Clopidogrel
Carotid Artery Diseases
Heparin
Cerebrovascular Trauma

Additional relevant MeSH terms:
Therapeutic Uses
Hematologic Agents
Nervous System Diseases
Platelet Aggregation Inhibitors
Cardiovascular Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009