ISRCTN58790500已完成4 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
The Belfast and Health Social Care Trust (BHSCT)0 个研究点目标入组 1,056 人开始时间: 2016年6月21日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,056
研究概览
简要总结
2018 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/30064517 protocol 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34192922/ results for total hip arthroplasty (added 20/01/2022) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34587808/ results for total knee arthroplasty (added 20/01/2022) 2022 Other publications in https://pubmed.ncbi.nlm.nih.gov/35816170/ Cost analysis (added 10/07/2023)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Awaiting primary elective hip or knee replacement
- •2. Both male & female
- •3. Aged between 18 and 100 years
排除标准
- •Current participant exclusion criteria as of 28/03/2018:
- •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 <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. Use of antiplatelet medication within 7 days of surgery* (Does not include aspirin if dose <300mg).Anticoagulant use within 7 days of surgery (thienopyridines, clopidogrel etc.)*
- •12. Direct thrombin inhibitors within 2 days of surgery*
- •13. Factor Xa inhibitors within 2 days of surgery*Xa inhibitors within 2 weeks of surgery*
- •14. The INR level is greater than or equal to 1.5 in a patient who has stopped warfarin in preparation for surgery 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 been using combined hormonal contraception (which includes combined oral contraception (COC), combined contraceptive transdermal patch and vaginal ring) within 4 weeks of surgery*.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
- •24. Patients unwilling to provide informed consent
- •25. Patients who present for simultaneous bilateral THA or TKA
- •26. Patients who are on renal dialysis and have an AV fistula
- •27. Patients who previously have been enrolled in this study
- •*These are patients with contra-indications to primary hip or knee replacement.
- •Original participant exclusion criteria
- •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/mm3at 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
研究者
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