Impact of a Biological Glue (Evicel®) on the Peri Operative Bleeding in Total Knee Prothesis Surgery
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Study the impact of a biological glue administration on the bleeding loss at Day 5 after a total knee prosthesis surgery operation
研究概览
简要总结
Knee prothesis surgery is responsible of a risk of thrombosis and hemorrhage. To prevent thrombosis, patients have systematic anticoagulation after surgery which are responsible of hemorrhage. A local glue which improve local coagulation and have no impact of thrombosis can be a solution to limit hemorrhage. The purpose of this trial is to study the impact of a biological glue administration on the bleeding loss at five days after a total knee prosthesis surgery operation.
详细描述
The orthopaedic surgeon administers a local pulverisation of the biological glue during the surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient affiliated with or a beneficiary of a social security category:
- •having more than 18 years old
- •having signed the informed consent form
- •having undergone a total knee prosthesis surgery operation
排除标准
- •incapacity to understand the protocol
- •patient having taken anti-coagulants or clopidogrel 10 days before excepted aspirin to a dose equal or less than 160 mg/day
- •women having period so generally women having less than 50 years old
- •PT less than 60% and ACT taller than 10 sec
- •contra-indications to the drug
- •Erytropoietine treatment required before surgery
研究组 & 干预措施
Evicel
干预措施: Human Fibrinogen and human thrombin (Evicel) (Drug)
Placebo
干预措施: Sodium Chlorure (Physiological saline) (Drug)
结局指标
主要结局
Study the impact of a biological glue administration on the bleeding loss at Day 5 after a total knee prosthesis surgery operation
时间窗: Day 5
次要结局
- The site incision state(Day 1, Day 3, Day 5 and at the hospitalisation end)
- The rest and movement pain(Day 1, Day 3, Day 5 and at the hospitalisation end)
- The antalgic consumption(Day 1, Day 3, Day 5 and at the hospitalisation end)
- The rate of SUSARs.(Between Day 1 and the end of the study (6 months post-operative))
- The rate of red blood cell transfusion(Day 1, Day 3, Day 5 and at the hospitalisation end)
- The rate of cell saver transfusion the surgery day(Day 0)
- The hematoma size(Day 1, Day 3, Day 5 and at the hospitalisation end)
- Major rate or clinically significative hemorrhage.(Between Day 1 and the hospitalisation end)
- Infectious complications.(Between Day 1 and the hospitalisation end)
- The functional recovering index(Day 1, Day 3, Day 5, at the hospitalisation end and at 1 month, 3 months and 6 months post-operative)
- The rate ot thrombotics events.(Between Day 1 and the hospitalisation end)