Role of Intravenous Tranexamic Acid Use in Patients Undergoing Breast Free Flap Reconstruction: Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Transfusion rate
研究概览
简要总结
Tranexamic acid (TXA) is a synthetic, competitive lysine receptor inhibitor on plasminogen. It ultimately stabilizes the fibrin matrix, therefore used as a hemostatic agent for various indications. While there has been indications for orthopedic and trauma surgery, there is no clear data for its role in patients who are undergoing free tissue transfer. Studies have shown that patients undergoing free tissue transfer can have transfusion rates ranging from 7.2% to 34.9%, which data also showing association between transfusion requirement and higher free flap failure rate. There has been a few retrospective studies that evaluated the effect of TXA in free tissue transfer and the results showed no increased risk of microanastomosis failure but some showing decreased blood loss. This study aims to further analyze the role of TXA in patients undergoing breast free flap reconstruction with randomized, prospective trial. Control group will not receive TXA while experimental group will receive TXA. Both groups will receive standard of care breast free flap surgery as well as post-op care, which is streamlined with Early Recovery After Surgery (ERAS) protocol. Their pre and post-op hemoglobin will be compared, as well as rates of transfusion, surgical outcome and surgical complications including hematoma, flap failure, and any other medical complications such as Deep Vein Thrombosis (DVT)/ Pulmonary Embolism (PE).
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)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •All female patients who are 18 years or older who will undergo unilateral or bilateral abdomen-based free flap breast reconstruction at UVA Medical Center
排除标准
- •Subjects with ages <18 years
- •Allergy to TXA
- •Subjects who has contraindications to TXA: anyone who has active intravascular thrombosis or anyone with subarachnoid hemorrhage
- •Subjects who have anemia (defined as baseline hemoglobin <8 g/dL
- •Subjects who cannot read or understand English
- •Subjects who are pregnant
研究组 & 干预措施
TXA group
Women undergoing immediate or delayed free flap breast reconstruction and receiving IV TXA
干预措施: Tranexamic acid (Drug)
Placebo group
Women undergoing immediate or delayed free flap breast reconstruction and receiving same volume of IV saline
干预措施: Placebo (Drug)
结局指标
主要结局
Transfusion rate
时间窗: Typically 0-72 hours after surgery
Transfusion rate during hospital stay
Delta Hemoglobin
时间窗: 1 day after surgery
Post-op day 1 Hemoglobin - Pre-op Hemoglobin
次要结局
- Length of Stay(typically 2-4 days)
- Surgical complications(30 days after surgery)
研究者
John Stranix
Assistant Professor of Plastics Surgery
University of Virginia
