The Etiologic Role of Inflammation, Thrombophilia and Fibrinolysis in the Post-thrombotic Syndrome: The Bio-SOX Sub Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 803
- 试验地点
- 25
- 主要终点
- Markers of Inflammation
研究概览
简要总结
The purpose of this study is to evaluate whether biomarkers of inflammation, genetic thrombophilia and coagulation activation influence Post-Thrombotic Syndrome development in patients with symptomatic proximal deep venous thrombosis.
详细描述
The post-thrombotic syndrome (PTS) is a frequent, burdensome and costly condition that occurs in about one third of patients after an episode of deep vein thrombosis (DVT). Affected patients have chronic leg pain and swelling, and sometimes develop skin ulcers. Poor understanding of the pathophysiology and predictors of PTS has hampered progress in its prevention and treatment. Biomarkers reflective of inflammation, genetic thrombophilia and coagulation activation may be of value in predicting PTS development in patients with DVT; they may also provide insight into understanding the underlying mechanisms of PTS, which could result in the development and testing of novel therapies to prevent and treat PTS.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Consecutive patients with a first, symptomatic, objectively confirmed proximal DVT diagnosed within the last 14 days (with or without concurrent distal DVT or pulmonary embolism)
- •Who have no contraindications to standard treatment with heparin and/or warfarin, and
- •Who provide informed consent to participate
排除标准
- •Contraindication to compression stockings Limited lifespan (estimated < 6 months)
- •Geographic inaccessibility preventing return for follow-up visits
- •Inability to apply stockings daily and unavailability of a caregiver to apply stockings daily
- •Treatment of acute DVT with thrombolytic agents
结局指标
主要结局
Markers of Inflammation
时间窗: 6-month follow up
Blood samples drawn at baseline, 1 and 6-mths to evaluate the relationship between CRP, ICAM, IL-6, IL-10 with the subsequent development of PTS.
Markers of Other Thrombophilia
时间窗: 6-month follow up
Blood samples drawn at 6-mths to evaluate the relationship between D-Dimer, VIII, Lupus anticoagulant, IgG, IgM with the subsequent development of PTS.
次要结局
未报告次要终点
研究者
Dr. Susan Kahn
SOX Trial Principal Investigator
Sir Mortimer B. Davis - Jewish General Hospital