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临床试验/NCT00494156
NCT00494156撤回不适用

Anticoagulation in the Management of Grade I-III Blunt Cerebrovascular Injuries

C. Clay Cothren, MD2 个研究点 分布在 1 个国家开始时间: 2003年7月最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
撤回
发起方
试验地点
2
主要终点
Neurologic sequelae

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients greater than 18 years old with documented grade I-III blunt cerebrovascular injuries.

排除标准

  • Pregnancy
  • Nasal polyps
  • Previous gastrointestinal bleeding secondary to antiplatelet medications
  • Contraindication to systemic anticoagulation.

结局指标

主要结局

Neurologic sequelae

时间窗: during hospital visit

次要结局

未报告次要终点

研究者

发起方
C. Clay Cothren, MD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

C. Clay Cothren, MD

Principal Investigator

Denver Health and Hospital Authority

研究点 (2)

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