Effects of Tranexamic Acid for Alloplastic Breast Reconstruction: A Randomized Control Trial
试验速览
- 阶段
- 3 期
- 入组人数
- 106
- 试验地点
- 3
- 主要终点
- Seroma
研究概览
简要总结
Hematoma is a common complication of alloplastic breast reconstruction. This can lead to pain and discomfort experienced by the patient, in addition to greater use of valuable healthcare resources. Previous studies have shown correlation between the use of tranexamic acid (TXA), an anti-fibrinolytic, and reduced post-surgical bleeding complication events.
In this randomized control trial (RCT) assessing TXA use in alloplastic breast reconstruction, one breast will be randomized to have TXA applied topically, while the other will have normal saline (NS) placebo applied. The primary objective of this prospective blinded randomized control trial study is to determine if the administration of topical TXA in alloplastic breast reconstruction reduces the incidence of surgical site hematoma compared to placebo within 2 weeks following surgery. The results of this study will be used to inform the design of a larger multicentered RCT on TXA in breast surgery.
详细描述
The primary objective of this study is to investigate the use of topical application of tranexamic Acid (TXA) to the surgical wound as a means to decrease hematoma formation compared to placebo in patients undergoing alloplastic breast reconstruction. This project is designed as a single-center RCT to evaluate the effectiveness of topical TXA in this patient population.
If enrolled in this study, patients individual breasts will be randomly assigned to one of two treatment groups for to apply to the wound before it is closed.
One breast will have an intravenous form of TXA applied topically to the surgical site. The other will be have a topical normal saline solution applied to the wound before closure (a placebo).
The patients will have the standard number of drains and postoperative instructions for breast reconstruction. They will follow-up at two weeks time in clinic for assessment, and emergency room visits will be also be evaluated. Standard of care will be practiced with respect to all procedures and visits.
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
- Double (Participant, Care Provider)
盲法说明
Patients will be randomized on the REDCap system. Their assignment will be made available to research team member, which will be preparing syringes with either TXA or placebo.
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Are 18 years or older;
- •Are undergoing one- or two-stage bilateral alloplastic breast reconstruction immediately after bilateral mastectomy at either Hamilton Health Sciences or St. Joseph's Hospital Hamilton.
排除标准
- •Taking therapeutic anticoagulation;
- •Taking antiplatelet drugs;
- •Pregnant or breast feeding;
- •Allergic to TXA;
- •Cannot provide informed consent;
- •Alloplastic reconstruction is not performed immediately after mastectomy;
- •Have a documented coagulopathy or bleeding disorder, acquired disturbances of colour vision, subarachnoid hemorrhage, hematuria, irregular menstrual bleeding, or seizure disorder.
研究组 & 干预措施
Tranexamic Acid
3 grams of tranexamic acid (30 mL of 100 mg/mL solution) diluted in 10 mL of normal saline
干预措施: Tranexamic acid (Drug)
Normal Saline
40 mL topical of 0.9% normal saline
干预措施: Normal Saline (Drug)
结局指标
主要结局
Seroma
时间窗: 2 weeks
Incidence rate of seroma
Hematoma
时间窗: 2 weeks
Incidence rate of hematoma
次要结局
- Reoperation rate(2 weeks)
- Imaging findings(2 weeks)
- Drain output(24 hours)
- Days with drains(2 weeks)
- Reintervention rate(2 weeks)