An interventional study of heparin and aspirin and clopidogrel in Carotid Artery Injury and Vertebral Artery Injury, sponsored by C. Clay Cothren, MD. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-10-21.
Sponsored by C. Clay Cothren, MD · Not applicable, Interventional, and Prevention
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.
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Exclusion Criteria:
Neurologic sequelae
Time frame: during hospital visit
This study is withdrawn, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.
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Carotid Artery Injuries