ISRCTN23254458已完成未知
A double-blind, randomized controlled trial of the prevention of clinically important venous thromboembolism after isolated lower leg fractures.
niversity of Toronto (Canada)0 个研究点目标入组 700 人开始时间: 2006年2月24日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 700
研究概览
简要总结
- 2015 results in https://www.ncbi.nlm.nih.gov/pubmed/25900749 (added 31/01/2019)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Age >16 years, either sex
- •2. Unilateral or bilateral, closed or open, fractures of the lower extremity distal to the knee including:
- •a. Isolated fractures of the tibia including tibial plateau, shaft and plafond and medial malleolus
- •b. Isolated fractures of the fibula including fibular head, fibular diaphysis, distal fibula and lateral malleolus
- •c. Combined fractures of the tibia and fibula
- •3. Tibia and/or fibula fractures may be accompanied by fractures of the patella and/or foot as well as ligamentous injuries as long as either the tibia or the fibula is involved
- •4. Patients must be scheduled to undergo surgery (internal or external fixation) for repair of their fracture during the current admission
排除标准
- •1. Patients presenting greater than 72 hours after injury
- •2. Major injury involving other site(s)
- •3. Lower extremity vascular injury requiring surgical repair
- •4. Known systemic bleeding disorder or international normalized ratio (INR) >1.5, aPTT >40 sec, or platelets <50 x 10^9/l at baseline
- •5. Active, uncontrolled bleeding (as determined by the attending surgeon or delegate)
- •6. Intracranial or other major bleed in the previous 4 weeks
- •7. Ongoing need for anticoagulation for other reasons
- •8. Previous DVT or PE (objectively proven or treated with anticoagulants)
- •9. Known molecular hypercoagulable state
- •10. Active cancer
- •11. Inability to receive contrast dye because of pregnancy, contrast allergy, or renal failure (serum creatinine >300 µmol/l)
- •12. Hypersensitivity to heparin or LMWH (including history of HIT)
- •13. Inability to arrange out-of-hospital study medication administration
- •14. Anticipated inability to undergo endpoint duplex ultrasound or follow-up (day 14 + 2, 6 weeks, 3 months)
- •15. Inability or refusal to provide informed consent
- •16. Previous participation in this study
- •17. Estimated weight less than 40 kg
研究者
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