The Use of Evicel to Reduce Blood Loss in Total Knee Replacement Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Change in Hemoglobin on Day 0 Compared to Preoperatively
研究概览
简要总结
Application of "Evicel" hemostatic matrix during operation for unilateral total knee replacement surgery (TKA) will result in decreased bleeding and postoperative drain output, a reduction in transfusion requirements, and less reduction of hemoglobin.
详细描述
No additional data desired
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of degenerative joint disease of the knee in patients medically suitable to undergo unilateral total knee arthroplasty
排除标准
- •Known allergies to human blood products.
- •History of bleeding disorders.
- •Patients with previous arthrotomy, however, with exception of medial or lateral menisectomy.
- •Patients taking Lovenox, Plavix, Aggrenox or erythropoetin. (coumadin is acceptable)
- •Additionally, any patient with an intra-operative complication (i.e bone fracture, vascular injury) or post-operative complication that would affect bleeding tendency will be excluded although data will be recorded for later analysis. Also, any patient who has a complication with the suction drain (eg inadvertently being pulled out, suction failing) will have the remaining data points recorded and drain measurements will be excluded from analysis.
研究组 & 干预措施
Evicel
Evicel is a fibrin sealant used for hemostasis when control of bleeding by ligature or other conventional procedures is ineffective or impractical. It has been shown to stop bleeding in 2 minutes or less. Evicel is a combination of a biologic activated component containing human fibrinogen and topical thrombin that functions on wet, actively bleeding tissue. It is a bioresorbable and biocompatible agent.
干预措施: Evicel fibrin sealant (Drug)
结局指标
主要结局
Change in Hemoglobin on Day 0 Compared to Preoperatively
时间窗: preoperatively and on the day of surgery
Change in Hematocrit on Day 0 Compared to Preoperatively
时间窗: preoperatively and day of surgery
Change in Hemoglobin On Day 1 Compared to Preoperatively
时间窗: preoperatively and one day after surgery
Change in Hematocrit on Day 1 Compared to Preoperatively
时间窗: preoperatively and one day after surgery
Change in Hemoglobin on Day 2 Compared to Preoperatively
时间窗: preoperatively and two days after surgery
Change in Hematocrit on Day 2 Compared to Preoperatively
时间窗: preoperatively and two days after surgery
Drain Output
时间窗: 24 hours post-operatively
A measurement of the amount of blood drained from the knee.
Number of Autologous Transfusion Units Over the Course of the Hospital Stay
时间窗: perioperatively
Units of autologous transfusion for each patient over the course of the hospital stay (an average of 3 days) were recorded.
Units of Homologous Transfusion Over the Course of the Hospital Stay
时间窗: three days postoperatively
Units of homologous transfusion for each patient over the course of the hospital stay (an average of 3 days) were recorded.
次要结局
- Change in International Normalized Ratio (INR) Level on Day 2 Compared to Preoperatively(preoperatively and two days after surgery)
- Range of Motion on Day 3(3 days postoperatively)
- Visual Analog Pain Scale on Day 3(3 days postoperatively)
- Range of Motion at 6 Weeks(6 weeks postoperatively)
- Visual Analog Pain Scale (at Rest) at 6 Weeks(6 weeks postoperatively)
- Visual Analog Pain Scale (During Activity) at 6 Weeks(6 weeks postoperatively)
- Visual Analog Pain Scale (During Therapy) at 6 Weeks(6 weeks postoperatively)
- Visual Analog Pain Scale (At Night) At 6 Weeks(6 weeks postoperatively)