Tranexamic Acid in Radical Resection and Endoprosthetic Reconstruction: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Perioperative Blood Loss
研究概览
简要总结
This study intends to determine if any correlation exists between administration of TXA or not to musculoskeletal oncology patients undergoing endoprosthetic reconstruction and blood loss and blood transfusion rates.
详细描述
Resection of bony and soft tissue tumors with endoprosthetic reconstruction often presents a significant risk of perioperative blood loss requiring transfusion. Tranexamic acid (TXA) is an antifibrinolytic that is commonly used to reduce blood loss in orthopedic procedures, most often arthroplasty. The aim of this study is to determine in a randomized controlled fashion if there is any difference in perioperative blood loss and blood transfusion rates when TXA is used compared to when it is not used in patients undergoing radical resection of bone and soft tissue sarcomas with endoprosthetic reconstruction.
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
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing wide resection of a malignant bony tumor of the lower extremity with endoprosthetic reconstruction.
- •Patients undergoing a resection of soft tissue sarcoma measuring > 5cm.
排除标准
- •Patients undergoing revision endoprosthetic reconstruction
- •Patients with known coagulopathy
- •Known history of DVT or embolic disease
- •Benign tumors
- •Patients with allergy to TXA
- •Those refusing blood products
- •Those concurrently on anti-coagulant therapy
- •Pregnant and/or nursing women
- •Vulnerable populations as defined by the KUMC IRB
研究组 & 干预措施
Bony tumor treated with Tranexamic acid (TXA)
This group of participants will undergo a bony tumor resection of the femur or proximal tibia and endoprosthetic reconstruction with TXA.
干预措施: Tranexamic Acid (TXA) (Drug)
Soft tissue sarcoma treated with Tranexamic Acid (TXA)
This group of participants will undergo soft tissue sarcoma resection of the lower extremity with TXA
干预措施: Tranexamic Acid (TXA) (Drug)
结局指标
主要结局
Perioperative Blood Loss
时间窗: During surgical procedure, 4 to 6 hours
How much blood was lost during surgical process
次要结局
未报告次要终点
研究者
Kyle Sweeney, MD
Principal Investigator
University of Kansas Medical Center