Treatment of Upper Extremity Deep-Vein Thrombosis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 2
- 主要终点
- Percentage of Participants That Died at 3 Months
研究概览
简要总结
The purpose of this study is to document the long-term outcome or prognosis of patients diagnosed with upper extremity deep-vein thrombosis who are treated with Fragmin (dalteparin sodium injection) for three months.
详细描述
Upper extremity deep-vein thrombosis (DVT) is an increasingly common clinical problem and has been found to cause important pulmonary embolism in up to 36% of cases including fatal embolism. The major risk factor for development of DVT is presence of a central venous catheter in which up to 30% of patients may develop venous thrombosis. Peripherally inserted central catheters or (PICC) lines have been more frequently used in order to avoid the morbidity of central venous catheter insertion. There is little data on the incidence of DVT with these catheters, or effective treatment regimen.
The purpose of this study is to document the long-term outcome or prognosis of patients diagnosed with upper extremity deep-vein thrombosis who are treated with Fragmin (dalteparin sodium injection) for three months. About 100 patients will be enrolled in this study at the University of Oklahoma.
All patients with upper extremity DVT will be screened. Each will have a complete baseline and risk factor assessment.
All patients will receive active study drug for a period of 3 months with reassessment of upper extremity DVT by ultrasound.
All patients will participate for a period of 12 months with follow up visits at 5-7 day, and 1, 3, 6, 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- 否
入选标准
- •Patients with confirmed upper extremity DVT diagnosed by ultrasound imaging or venogram
排除标准
- •Active, clinically significant bleeding
- •Known hypersensitivity to heparin or low-molecular weight heparin
- •Currently pregnant or less than 1 week post-partum
- •Acquired bleeding diathesis
- •Known inherited bleeding disorder
- •Renal failure
- •Extremes of weight
- •Poor performance status
- •Unable to return for repeat diagnostic testing or follow-up visits
研究组 & 干预措施
Treatment of Upper Extremity DVT
Participants received dalterparin followed by warfarin or received dalterparin monotherapy for the treatment of upper extremity DVT
干预措施: Dalteparin sodium injection (Drug)
Treatment of Upper Extremity DVT
Participants received dalterparin followed by warfarin or received dalterparin monotherapy for the treatment of upper extremity DVT
干预措施: Warfarin (Drug)
结局指标
主要结局
Percentage of Participants That Died at 3 Months
时间窗: 3 months
New Venous Thromboembolism at 3 Months
时间窗: 3 months
New DVT or PE at 3 months confirmed by diagnostic testing
次要结局
- Bleeding Events(3 months)
研究者
Suman Rathbun
Professor of Medicine
University of Oklahoma