Comparison of Floseal® and Tranexamic Acid on Bleeding Control After Total Knee Arthroplasty - Randomized Prospective Study
试验速览
- 阶段
- 4 期
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Amount of bleeding
研究概览
简要总结
The total knee arthroplasty (TKA) is a well established option for the treatment of osteoarthritis in this joint. Nevertheless, there are still some concerns related to the peri-operative management of elderly patients, highlighting the complications related to medical comorbidity and bleeding produced by surgery. One of the proposed methods to decrease postoperative bleeding, which has been accumulating favorable evidence, is the use of tranexamic acid (TA). Several studies (including prospective randomized trials with placebo group) showed excellent results with TA intravenous administration during TKA, reducing the amount of bleeding, the drop in hemoglobin and the need for blood transfusion. Another alternative to minimize bleeding is the use of topical hemostatic agent Floseal®, composed of thrombin and bovine gelatin. This substance has presented significant benefits on bleeding control in several areas of medicine, including orthopedic surgery, but no action has yet been established in TKA. The main objective is to evaluate the amount of bleeding, the drop in hemoglobin and the need for blood transfusion after TKA, comparing the use of TA, Floseal® and a control group. The secondary objective is to evaluate the rate of adverse events in the studied groups.
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
- 年龄范围
- 21 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Indication for total knee arthroplasty
- •No previous knee surgery
- •Absence of inflammatory arthritis
- •Absence of stiff knee
- •Absence of the following factors: renal failure, liver failure, severe heart failure, respiratory failure, history of thromboembolic events, bleeding disorders, previous strokes
排除标准
- 未提供
研究组 & 干预措施
Tranexamic acid
A dose of tranexamic acid (10mg/Kg) will be administered 20 minutes before inflating the pneumatic tourniquet and another dose 15 minutes after the tourniquet release.
干预措施: Tranexamic acid (Drug)
Floseal®
Floseal® will be applied in regions of potential bleeding before the release of the pneumatic tourniquet.
干预措施: Floseal® (Drug)
结局指标
主要结局
Amount of bleeding
时间窗: First two days post-operative
Measure of the drain volume on the first two days post-operative
Drop in hemoglobin
时间窗: Three days postoperative
Difference between the preoperative hemoglobin and hemoglobin in the third postoperative
次要结局
- Adverse events(1 month)
研究者
Marco Kawamura Demange
Assistant Professor
University of Sao Paulo General Hospital
