Multi-centre, Double-blind, Randomized, Controlled Trial Comparing Intra-operative Regional Heparinization to Placebo for the Prevention of Deep Vein Thrombosis Following Total Knee Arthroplasty
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- DVT as determined by venography
研究概览
简要总结
The goal of this study is to prevent blood clots from forming during surgery and a few days after total knee replacement surgery. This study will help us identify whether using a blood thinner in the operating room will stop blood clots from forming during the operation.
详细描述
Venous thromboembolism is a major cause of morbidity and mortality after lower limb orthopaedic surgery in the adult patient. If, as suggested, DVT formation begins intra-operatively then targeting this period to prevent clot formation could substantially reduce DVT rates in the TKA population. The present study aims to determine whether this intra-operative regional heparinization technique is effective in preventing the intra-operative formation of DVT following TKA, as evidenced by venography in the early post-operative period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Undergoing unilateral primary total knee arthroplasty
- •Males and non-pregnant females ages 18-90 (pre-menopausal females will undergo a serum pregnancy test at screening)
- •Full weight bearing status (of non-operated leg) following surgery
- •Patient able to understand and willing to sign informed consent
排除标准
- •1) Known hypersensitivity to contrast media 2) Patients taking Metformin 3) Serum creatinine above 180Fmol/L 4) Platelets < 100 x 10 9/L, INR/PTT > 1.5 x normal 5) History of heparin induced thrombocytopenia 6) Allergy to heparin or fish 7) Prior use of protamine sulfate (i.e., protamine-containing insulin) 8) Vasectomized or infertile males 9) History of bleeding disorder 10) Bilateral total knee arthroplasty 11) History of stroke or myocardial infarction in previous 6 months 12) Traumatic spinal anaesthesia (two or more attempts and/or bloody) 13) History of previous DVT/PE 14) Active peptic ulcer disease (e.g., GI bleed, rectal bleed) 15) Currently on chronic anticoagulant therapy 16) Contra-indication to heparin 17) Patient is taking part in any other investigational study 18) Previous contralateral TKR or hip replacement
结局指标
主要结局
DVT as determined by venography
时间窗: 5 day post op
次要结局
- Bleeding rate Rate of PE Complication Rate(2 week post op)