Evaluation of Efficacy and Safety of Perioperative Tranexamic Acid During Primary Total Knee Arthroplasty: A Randomized, Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- intra-operative blood loss
研究概览
简要总结
Tranexamic acid is a medication used to treat or prevent excessive blood loss during surgery. Previous studies have shown tranexamic acid (TXA) reduces blood loss and post-operative blood transfusion rate without significant complications. In addition, many meta-analyses have confirmed these results. This study also aims to determine how safe and effective tranexamic acid treatment is for different patients undergoing primary total knee arthroplasty.
详细描述
Tranexamic acid (TXA) is used to control both intraoperative (IO) and postoperative (PO) bleeding during various surgical procedures. Moreover, TXA was found to indirectly reduce post-surgery infection rates and decrease hemorrhage-related mortality in trauma patients. This study aims to determine how safe and effective tranexamic acid treatment is for patients undergoing primary total knee arthroplasty. The study is a prospective, randomized, triple-blinded, placebo-controlled study. Ninety participants were enrolled between July 2021 and September 2022 and followed up with every patient for six months.
The study was done in Damascus, Syria. Participants were randomly assigned following simple randomization procedures (computerized random numbers) to 1 of 2 groups. The allocation was put into concealed envelopes independent of the surgeon and the author, and the randomization was performed by a research fellow who was not involved in patient care. Participants who went unilateral primary TKA and did not use TXA, just IV normal saline (0.9% sodium chloride), formed the control group. In contrast, the intervention group comprised participants who went primary unilateral TKA and used two-dose intravenous tranexamic acid that was applied as follows: 10mg/kg of Tranexamic Acid in 100 Milliliters（ml) normal saline (0.9% sodium chloride), the first dose 15 minutes before the tourniquet deflation and the second dose at 180 minutes after the first dosage.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
triple Blinded
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with primary knee osteoarthrosis who underwent unilateral primary TKA
排除标准
- •Known allergic reaction to tranexamic acid
- •Secondary arthritis (ex., Rheumatic arthritis, traumatic arthritis, septic arthritis)
- •BMI less than 20 and more than
- •Patients having vascular or hematologic disease.
- •Patients who were taking anti-coagulant medicine and couldn't stop it.
- •Patients having acute or chronic renal failure.
- •Patients classified as the AAA as grade four or five.
- •Patients with intra-operative complications such as intra-operative fractures or vascular injuries.
- •Post-traumatic and secondary knee arthritis patients.
- •Revisions and complex primary cases.
- •Patients with an active infection or a history of lower limp infection.
研究组 & 干预措施
intravenous tranexamic acid
The intervention group comprised patients who went primary unilateral TKA and used two-dose intravenous tranexamic acid that was applied as follows: 10mg/kg of Tranexamic Acid in 100 Milliliters（ml) normal saline (0.9% sodium chloride), the first dose 15 minutes before the tourniquet deflation and the second dose at 180 minutes after the first dosage.
干预措施: Tranexamic Acid 100 MG/ML (Drug)
placebo
The control group comprised primary unilateral TKA patients who did not use TXA, just IV normal saline (0.9% sodium chloride).
干预措施: Normal saline (Drug)
结局指标
主要结局
intra-operative blood loss
时间窗: measured during surgery time (From the time of the surgical incision at the beginning of the operation until the time of wound closure at the end of the operation), Which equals about an hour
the amount of lost blood intraoperatively and will be measured by calculating the increased weight of the utilized wet mops and the volume of the suction bottle after erasing the amount of the used lavage
post-operative blood loss
时间窗: measured once 2 days after surgery
the amount of lost blood postoperatively will be calculated as the output of the drain bottle
Total Blood Loss（TBL）
时间窗: calculated by an equation at the 72h postoperative
Total Blood Loss（TBL） in the perioperative period was calculated using the Gross formula, which is estimated by hitting the patients' blood volume by the difference between pre and post-operative hematocrit value divided by the initial hematocrit value
hidden blood loss
时间窗: measured once 3 days after surgery
the amount of lost blood in the tissues that were not measured intraoperatively or postoperatively and will be calculated using the difference between total blood loss and intra and post-operative blood loss
次要结局
- perioperative complication(assesed if happened within month interval untill 6 months after surgery)
- Transfusion rates(from the day of surgery to the day of discharge,an expected average of 3 days)