The Effectiveness Of Intravenous Tranexamic Acid (TXA) on Reducing Perioperative Blood Loss For Patients Undergoing Periacetabular Osteotomy (PAO): A Randomized Double Blind Placebo Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Blood loss
研究概览
简要总结
In this research study the investigators want to learn more about how a medication called tranexamic acid (TXA) could help reduce bleeding during Periacetabular Osteotomy (PAO) surgery. TXA is approved by the Food and Drug Administration (FDA) for the reduction of bleeding for many types of surgical procedures. TXA works by slowing the breakdown of blood clots and helps to prevent bleeding. From previous studies, TXA has been shown to effectively prevent bleeding in patients undergoing heart, spine and skull remodeling surgeries.
As PAO surgery has been associated with significant blood loss when compared to other types of joint surgeries. In order to try and avoid bleeding that may lead to complications, different strategies can be used. In this research study the investigators want to learn more about how a medication called tranexamic acid (TXA) could help reduce bleeding during PAO surgery.
详细描述
This prospective randomized placebo controlled double blind trial will enroll 80 adolescents and young adults undergoing elective peri-acetabular osteotomy (PAO). The primary aim is to determine if intravenous infusion of TXA during surgery is effective compared to standard care (no TXA) in decreasing blood loss (measured; and calculated) and blood transfusion (autologous and allogenic) perioperatively in adolescents and young adults presenting for PAO surgery. The rate of blood loss over time will be measured and compared between groups with adjustment for length of surgery (time; hours) and body weight (kg).
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, Outcomes Assessor)
入排标准
- 年龄范围
- 13 Years 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 13-35 years
- •Scheduled for primary unilateral PAO +/- arthroscopy
排除标准
- •Hematologic disorder, thrombocytopenia (Platelet count <140,000/uL3)
- •Major hepatic, renal, or vascular disorder
- •Active Thromboembolic disorder
- •Color vision defect
- •TXA allergy
- •Taking anticoagulants or antiplatelet drugs (heparin, warfarin, clopidogrel)
- •Ethical and/or religious objection to receiving blood products
- •International patients
- •Patients undergoing revision surgery
- •Patients undergoing combined PAO and other surgeries such as surgical dislocation, proximal femoral osteotomy
研究组 & 干预措施
Normal saline placebo
the participant will get saline 0.9% intravenous infusion for the duration of the surgery
干预措施: Normal saline (Drug)
Intravenous Tranexamic acid
Intravenous TXA will be given as a loading dose over 15 minutes of 30 mg/kg bolus (within an hour prior to surgical incision) and 10 mg/kg/hr infusion for the duration of the surgery
干预措施: Tranexamic Acid (Drug)
结局指标
主要结局
Blood loss
时间窗: 1 week after surgery
ml
次要结局
- Plasma TXA level(24 hours)
研究者
Susan Goobie
Associate Professor of Anaesthesiology, Harvard Medical School Associate in Perioperative Anesthesia, Boston Children's Hospital Clinical Director, Pharmacokinetics Laboratory.
Boston Children's Hospital