EUCTR2015-002661-36-GB进行中（未招募）1 期
Single centre randomised controlled trial to assess the effect of the addition of twenty-four hours of oral tranexamic acid post-operatively to a single intra-operative intravenous dose of tranexamic acid on calculated blood loss following primary hip and knee arthroplasty. - Influence of tranexamic acid on blood loss in total joint replacement
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,166
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Patients awaiting primary elective hip or knee replacement in the Primary Joint Unit at Musgrave Park Hospital.
- •2. Patients greater than or equal to 18 years of age.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 583
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 583
排除标准
- •1.Patients who do not pass a pre-operative assessment for elective total hip or knee arthroplasty (THA/TKA)
- •2.Fractured neck of femur
- •3.Haemophiliac or coagulation disorders that require TXA
- •4.Allergy to tranexamic acid or any of its excipients
- •5.Platelets less than 75,000/mm3 at pre-operative assessment*
- •6.Patients on active treatment for venous thromboembolism (VTE) (deep vein thrombosis (DVT), pulmonary embolisms (PE)) within 6 months of surgery*
- •7.History of VTE within 6 months of surgery*
- •8.Patients who have had a myocardial infarction (MI) within 12 months*
- •9.Cardiac stent within 12 months of surgery*
- •10.Patients who have had a stroke (cerebrovascular accident (CVA)) or transient ischemic attack (TIA) within 9 months of surgery*
- •11.Anticoagulant use within 7 days of surgery (thienopyridines, clopidogrel etc.*
- •12.Direct thrombin inhibitors within 2 days of surgery*
- •13.Xa inhibitors within 2 weeks of surgery*
- •14.Patients who have stopped Warfarin in preparation for surgery but have an INR level greater than or equal to 1.5*
- •15.Hepatic failure*
- •16.Patients with epilepsy
- •17.Patients requiring therapeutic anticoagulation post-operatively eg. metallic heart valves.
- •18.Pregnant women, women who have not yet reached the menopause (no menses for = 12 months without an alternative medical cause) who test positive for pregnancy, are unwilling to take a pregnancy test prior to trial entry
- •19.Patients who have taken the combined oral contraceptive pill within 4 weeks of surgery*
- •20.Female patients who are breastfeeding
- •21.Treated with any other investigational medication or device within 60 days
- •22.Patients unable to provide informed consent
- •23.Patients who are unable or unwilling to commit to the study schedule of events
- •*These are patients with contra-indications to primary hip or knee replacement.
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