The Role of Local Tranexamic Acid on Periorbital Oculoplastic Surgery
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 主要终点
- Postoperative patient ecchymosis
研究概览
简要总结
This study investigates the effect of tranexamic acid, a medication that helps reduce bleeding, in patients undergoing surgeries around their eyes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Adults age 18 and above undergoing periorbital oculoplastic surgery including but not limited to upper and lower blepharoplasty, four lid procedures, or dacryocystorhinostomy (DCR).
排除标准
- •- Adults unable to consent
- •Individuals less than 18 years of age
- •Prisoners
- •Pregnant women.
- •Known contradictions or sensitivities to study medication (tranexamic acid)
- •Patients with known prior thromboembolic events
- •Previous eyelid surgery or same-side DCR (RE-DCR)
- •Has any type of coagulopathy
研究组 & 干预措施
Tranexamic Acid Group
Participants undergoing standard of care periorbital procedures will be randomized to receive tranexamic acid with lidocaine/epinephrine on one of their eyelids at the beginning of the scheduled operation before incision.
干预措施: Tranexamic acid (Drug)
Placebo Group
Participants undergoing standard of care periorbital procedures will be randomized to receive balanced salt solution with lidocaine/epinephrine on one of their eyelids at the beginning of the scheduled operation before incision.
干预措施: Placebo (Drug)
结局指标
主要结局
Postoperative patient ecchymosis
时间窗: Up to 3 months
Ecchymosis will be graded 0-3 based on location and degree based on a previously reported validated scale (higher scores with more ecchymosis)
次要结局
- Patient-perceived outcomes(Up to 3 months)
- Postoperative patient chemosis(Up to 3 months)
- Eyelid edema(Up to 3 months)
- Intraoperative patient bleeding(Postoperative day 0 (day of surgery))
- Physician Perception of Intraoperative Bleeding(Postoperative day 0 (day of surgery))
研究者
Wendy Lee
Professor of Clinical Ophthalmology
University of Miami