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临床试验/NCT06428682
NCT06428682招募中4 期

Role of Intravenous Tranexamic Acid Use in Patients Undergoing Breast Free Flap Reconstruction: Randomized Controlled Trial

University of Virginia1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年5月13日最近更新:
适应症
干预措施
相关药物

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

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

Experimental

Women undergoing immediate or delayed free flap breast reconstruction and receiving IV TXA

干预措施: Tranexamic acid (Drug)

Placebo group

Placebo Comparator

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

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

John Stranix

Assistant Professor of Plastics Surgery

University of Virginia

研究点 (1)

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