Compression stockings to prevent post-thrombotic syndrome: a multicentre, two arm, placebo-controlled randomised parallel device trial

Sir Mortimer B. Davis Jewish General Hospital-Mtl (Canada)0 个研究点目标入组 800 人开始时间: 2005年9月1日最近更新: 2016年10月17日

适应症

试验速览

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•Current inclusion criteria (protocol updated in August 2008):
•Consecutive patients aged greater than or equal to 18 years old, either sex, with a first, symptomatic, objectively confirmed proximal DVT diagnosed within the last 14 days (with or without concurrent distal DVT or Pulmonary Embolism [PE]) who have no contraindications to standard treatment with heparin and/or warfarin, and who provide informed consent to participate.
•Previous inclusion criteria (January 2005):
•Consecutive patients aged greater than or equal to 18 years old, either sex, with a first, symptomatic, objectively confirmed proximal DVT diagnosed within the last 10 days (with or without concurrent distal DVT or Pulmonary Embolism [PE]) who have no contraindications to standard treatment with heparin and/or warfarin, and who provide informed consent to participate.
•Initial inclusion criteria (January 2004):
•Consecutive patients with a first, symptomatic, objectively confirmed proximal DVT diagnosed within the last 72 hours (with or without concurrent distal DVT or Pulmonary Embolism [PE]) who have no contraindications to standard treatment with heparin and/or warfarin, and who provide informed consent to participate.

•Current exclusion criteria (protocol updated in January 2005):
•1. Contraindication to compression stockings
•2. Limited lifespan (estimated less than six months)
•3. Geographic inaccessibility preventing return for follow-up visits
•4. Inability to apply stockings daily and unavailability of a caregiver to apply stockings daily
•5. Treatment of acute DVT with thrombolytic agents
•Previous exclusion criteria:
•1. Contraindication to compression stockings
•2. Contraindication to celecoxib
•3. History of warfarin, aspirin or Non-Steroidal Anti-Inflammatory Drug (NSAID)-associated major haemorrhagic event
•4. Regular, daily use of NSAIDs
•5. Inability/unwillingness to stop anti-platelet drugs for 30 days
•6. Limited lifespan (estimated less than six months)
•7. Geographic inaccessibility preventing return for follow-up visits
•8. Inability to apply stockings daily and unavailability of a caregiver to apply stockings daily
•9. Treatment of acute DVT with thrombolytic agents

发起方

Sir Mortimer B. Davis Jewish General Hospital-Mtl (Canada)