NCT05441592已完成4 期
A Randomized Control Trial Assessing the Effect of Topical Tranexamic Acid on Risk of Hematoma in Breast Surgery
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 107
- 试验地点
- 1
- 主要终点
- Hematomas
研究概览
简要总结
This trial is being completed to evaluate the safety and efficacy of topical tranexamic acid use in preventing hematomas in routine breast plastic surgery operations.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing bilateral breast reduction or bilateral gender-affirming mastectomy
- •For patients undergoing bilateral breast reduction, any skin incision pattern or pedicle is acceptable.
- •For patients undergoing bilateral gender-affirming mastectomy, any skin incision and mastectomy type is acceptable
排除标准
- •Active thromboembolic disease or history of intrinsic risk of thrombosis or thromboembolism, including retinal vein or artery occlusion
- •Current use of systemic anticoagulation
- •Hypersensitivity to tranexamic acid
- •Concomitant use of combined hormonal contraceptives
- •Use of factor IX complex concentrates, anti-inhibitor coagulant concentrates or all-trans retinoic acid
- •History of acquired defective color vision
- •History of subarachnoid hemorrhage
- •Pregnancy
- •History of renal impairment or serum Creatinine >1.5 milligrams per deciliter (mg/dL)
研究组 & 干预措施
Irrigation that contains tranexamic acid (TXA)
Experimental
干预措施: Tranexamic acid injection (Drug)
No additional irrigation usual care
Other
干预措施: No additional irrigation (Other)
结局指标
主要结局
Hematomas
时间窗: Up to approximately 4 weeks after surgery
Results reflect the number of hematomas that occurred during the trial, requiring operative washout or aspiration in participants who received TXA versus participants who did not receive TXA.
次要结局
- Participants Who Experienced a Major Thromboembolic Event Related to the Study Drug(Up to approximately 4 weeks after surgery)
- Participants Who Experienced Major Complications Other Than Hematoma(Up to approximately 4 weeks after surgery)
研究者
Edwin G. Wilkins
Professor of Surgery
University of Michigan
研究点 (1)
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