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Anticoagulation in Blunt Cerebrovascular Injuries

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. Identifier: NCT00494156
Recruitment Status : Withdrawn (Study halted prematurely prior to enrollment of first participant.)
First Posted : June 29, 2007
Last Update Posted : October 21, 2015
Information provided by (Responsible Party):
C. Clay Cothren, MD, Denver Health and Hospital Authority

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.

Condition or disease Intervention/treatment Phase
Carotid Artery Injury Vertebral Artery Injury Drug: heparin Drug: aspirin and clopidogrel Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Anticoagulation in the Management of Grade I-III Blunt Cerebrovascular Injuries
Study Start Date : July 2003
Estimated Primary Completion Date : July 2008
Estimated Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners
Drug Information available for: Heparin

Primary Outcome Measures :
  1. Neurologic sequelae [ Time Frame: during hospital visit ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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 identifier (NCT number): NCT00494156

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United States, Colorado
Denver Health Medical Center
Denver, Colorado, United States, 80204
Sponsors and Collaborators
C. Clay Cothren, MD
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Principal Investigator: Clay Cothren, MD Denver Health Medical Center

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Responsible Party: C. Clay Cothren, MD, Principal Investigator, Denver Health and Hospital Authority Identifier: NCT00494156    
Other Study ID Numbers: COMIRB 00-508
First Posted: June 29, 2007    Key Record Dates
Last Update Posted: October 21, 2015
Last Verified: October 2015
Additional relevant MeSH terms:
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Carotid Artery Injuries
Wounds and Injuries
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Cerebrovascular Trauma
Trauma, Nervous System
Vascular Diseases
Cardiovascular Diseases
Physiological Effects of Drugs
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents