ISRCTN73819751已完成未知
Extended anticoagulation treatment for venous thromboembolism (VTE): a prospective multicentre randomised controlled trial
niversity of Birmingham (UK)0 个研究点目标入组 281 人开始时间: 2010年9月13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
- 281
研究概览
简要总结
2013 protocol in http://www.ncbi.nlm.nih.gov/pubmed/23497371 2019 results in https://www.ncbi.nlm.nih.gov/pubmed/31891148 (added 02/01/2020) 2020 results in https://pubmed.ncbi.nlm.nih.gov/32453520/ (added 05/03/2021)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Aged 18 years or over, either sex
- •2. Diagnosis of first unprovoked proximal deep vein thrombosis (DVT) or pulmonary embolism (PE)
- •3. On treatment with anticoagulants
- •4. Have completed 3 - 6 months of anticoagulant therapy (target 2 - 3)
排除标准
- •1. Patients under the age of 18 years
- •2. Patients with another indication for long term warfarin therapy, e.g., atrial fibrillation
- •3. Patients with a diagnosis of first unprovoked proximal DVT or PE who are no longer on anticoagulation therapy
- •4. Patients with a high risk of bleeding as evidenced by any of the following:
- •4.1. Patients with a previous episode of major bleeding where the cause was not effectively treated
- •4.2. Known thrombocytopaenia with a platelet count of less than 120 x 10^9 /L
- •4.3. Known chronic renal failure with a creatinine of more than 150 umols/L (1.7 mg/dl) or estimated glomerular filtration rate (eGFR) less than 30
- •4.4. Known chronic liver disease with a total bilirubin of more than 25 umols/L (1.5 mg/dl)
- •4.5. Active peptic ulcer
- •4.6. Poor compliance with, or control of, anticoagulation therapy during initial treatment (International Normalised Ratio [INR] control less than 50% time in range)
- •4.7. Patients requiring dual antiplatelet therapy (e.g., aspirin and clopidrogel)
- •5. Patients with a vena cava filter in place
- •6. Patients who have had a d?dimer test performed within 2 months of potential enrolment other than for evaluation for suspected recurrent VTE that was not confirmed
- •7. Patients whose GP expects their life expectancy to be less than 5 years
- •8. Patients unable to attend follow up visits due to geographic inaccessibility
- •9. Patients participating in a competing investigation
- •10. Patients with known antiphospholipid syndrome or known deficiency
- •11. Patients with a diagnosis of active cancer
- •12. Patients unwilling to give consent
研究者
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