Anticoagulation in Blunt Cerebrovascular Injuries
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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. 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 | Intervention |
|---|---|
|
Carotid Artery Injury Injury of Vertebral Artery |
Drug: heparin Drug: aspirin and clopidogrel |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Anticoagulation in the Management of Grade I-III Blunt Cerebrovascular Injuries |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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.
Contacts and Locations| United States, Colorado | |
| Denver Health Medical Center | |
| Denver, Colorado, United States, 80204 | |
| Principal Investigator: | Clay Cothren, MD | Denver Health Medical Center |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00494156 History of Changes |
| Other Study ID Numbers: | COMIRB 00-508 |
| Study First Received: | June 25, 2007 |
| Last Updated: | March 4, 2011 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Carotid Artery Injuries Carotid Artery Diseases Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Cerebrovascular Trauma Trauma, Nervous System Vascular Diseases Cardiovascular Diseases Wounds and Injuries Heparin Clopidogrel Anticoagulants |
Hematologic Agents Therapeutic Uses Pharmacologic Actions Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents Platelet Aggregation Inhibitors Purinergic P2Y Receptor Antagonists Purinergic P2 Receptor Antagonists Purinergic Antagonists Purinergic Agents Neurotransmitter Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 16, 2013