Management of Superficial Thrombophlebitis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Thrombosis Progression and Venous Thromboembolism (VTE)
研究概览
简要总结
The purpose of this study is to test the hypothesis that Fragmin (dalteparin sodium) subcutaneously once daily for 7 days is more effective than Ibuprofen given orally three times daily for 7 days for the treatment of superficial thrombophlebitis (STP).
详细描述
Superficial thrombophlebitis is a common problem and is thought to affect up to 20% of patients with varicose veins. In the absence of treatment, STP may cause its greatest morbidity with extension of thrombus into the deep venous system and resultant risk of pulmonary embolism.
Current standard therapy for STP consists of local heat, elevation of the extremity, and non-steroidal anti-inflammatory medication. However, no study to date has adequately evaluated the effectiveness of this therapy despite persistence and recurrence of symptoms of STP in many patients.
The purpose of this study is to document the outcome of patients with objectively documented STP who are treated with NSAID therapy (standard care) verses those treated with low-molecular weight heparin (dalteparin sodium) according to a pre-defined treatment regimen.
All patients with documented upper or lower STP will be screened. Each will have a complete baseline and risk factor assessment.
All patients will be randomized in one of two treatment groups:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 or lower extremity superficial thrombophlebitis by ultrasound imaging
排除标准
- •Active, clinically significant bleeding
- •Known hypersensitivity to NSAIDS, heparin or derivatives
- •Currently pregnant or < 1 week post-partum
- •Acquired bleeding diathesis
- •Known inherited bleeding disorder
- •Renal failure
- •Extremes of weight
- •unable to return for repeat diagnostic testing or follow-up visit
- •Concurrent deep-vein thrombosis
研究组 & 干预措施
Ibuprofen
Ibuprofen 800mg tid X 7 days + additional 7 days determined by protocol
干预措施: Dalteparin sodium injection (Drug)
结局指标
主要结局
Thrombosis Progression and Venous Thromboembolism (VTE)
时间窗: Day 14
Thrombosis progression and deep vein thrombosis at day 14 by ultrasound testing
Thrombosis Progression or Venous Thromboembolism (VTE) at 3 Months
时间窗: 3 months
Symptomatic thrombosis extension (DVT) or pulmonary embolism at 3 months documented by radiologic testing.
次要结局
- Change From Baseline to Day 14 in Pain Assessment(Day 1, Day 14)
- Major and Minor Bleeding Secondary to Dalteparin and Ibuprofen Treatment During the 3 Month Follow up.(3 months)