Vertebral Artery Injury Clinical Trial
Official title:
Anticoagulation in the Management of Grade I-III Blunt Cerebrovascular Injuries
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.
n/a
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT06383650 -
Use of 81 vs 325mg of ASA in Treatment of BCVI
|
Early Phase 1 |