跳至主要内容
临床试验/NCT02152917
NCT02152917Unknown4 期

Comparison of Floseal® and Tranexamic Acid on Bleeding Control After Total Knee Arthroplasty - Randomized Prospective Study

University of Sao Paulo General Hospital1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2014年2月最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

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®

Active Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Marco Kawamura Demange

Assistant Professor

University of Sao Paulo General Hospital

研究点 (1)

Loading locations...

相似试验