The Use of Fibrin Sealant to Reduce Bleeding After Total Knee Replacement
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Fall in post-operative hemoglobin level after total knee replacement
研究概览
简要总结
A randomized controlled study is performed to address the question of whether the topical application of a novel fibrin sealant, Evicel (Johnson & Johnson Wound Management, Ethicon, Somerville, NJ) in patient undergoing total knee replacement (TKR) reduce the perioperative blood loss and the need for allogenic blood transfusion compared to a control group. We hypothesize that fibrin sealant decrease the drop in post-operative hemoglobin level after total knee replacement.
详细描述
Total knee replacement is an invasive surgical procedure that can expose patients to massive perioperative bleeding. This hematic loss results in a high rate of blood transfusion after total knee replacement (TKR) with an incidence from 10% to 58%.Methods to prevent the need for allogenic blood transfusion after TKR include hemodilution, perioperative blood salvage and reinfusion, hypotensive anesthesia, preoperative autologous blood donation and intravenous administration of tranexamic acid.
In the last decade, the topical use of fibrin sealant has become a logical surgical stratagem for reducing blood loss in total knee arthroplasty.Fibrin sealants mimic the final step of the coagulation cascade reducing blood loss and transfusion requirements.
A novel hemostatic agent derived from banked allogenic human plasma (EVICEL, Johnson & Johnson Wound Management, Ethicon, Somerville, NJ) is recently available on the market for a variety of surgical specialty.
A randomized controlled study is conducted to test if the post-operative reduction in hemoglobin level would be lower in the fibrin sealant group compared to a control group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patient scheduled for TKR
- •written informed consent
- •diagnosis of osteoarthritis
排除标准
- •previous intervention on the same Knee (except for meniscectomy)
- •Hb pre-operative level lower than 12g/dl for man and 11g/dl for woman
- •Anticoagulation therapy or any anti-aggregate treatment not suspended at least 4 days before surgery
研究组 & 干预措施
Evicel
干预措施: Evicel (Drug)
结局指标
主要结局
Fall in post-operative hemoglobin level after total knee replacement
时间窗: First 7 days after surgery
Hemoglobin values are collected in patients in first week post surgery to assess how these values have changed.
次要结局
- total blood loss(until 7 day after surgery)
- Blood Transfusion rate(until 1 week after Surgery)
研究者
Pietro Randelli, MD
MD
University of Milan