Effects of Intravenous Tranexamic Acid During Rhytidectomy - a Randomized, Controlled, Double-blind Pilot Study
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Intraoperative bleeding
研究概览
简要总结
This is a prospective, randomized, double-blind study investigating whether intravenous tranexamic acid has any effect on rhytidectomy surgery, or the subsequent postoperative sequelae. Intraoperative bleeding and postoperative ecchymosis and edema are subjectively rated and complications are noted.
详细描述
This is a prospective, randomized, double-blind pilot study investigating whether intravenous tranexamic acid has any effect on rhytidectomy surgery, or the subsequent postoperative sequelae. Intraoperative bleeding is rated on a scale of mild, moderate, or severe and given a score of 1-3. Postoperative ecchymosis and edema are subjectively rated by both patient and surgeon on postoperative days 1, 6, and 9 using a similar mild/moderate/severe scale and scored 1-3, respectively. Any surgical or postoperative complications are noted. Scores are aggregated for statistical analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Only the CRNA who is administering the medications is unmasked until completion of the data collection period.
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Undergoing rhytidectomy surgery at Glasgold Group Plastic Surgery
排除标准
- •History of bleeding disorder, history of thromboembolic events, history of seizure, active use of oral contraceptive pills or hormone replacement therapy, participant preference
研究组 & 干预措施
Control Group
Intravenous normal saline (50cc) given over 15 minutes starting just prior to skin incision, and repeated 4 hours later
干预措施: Normal Saline 0.9% Infusion Solution Bag (Drug)
TXA Group
One gram of intravenous tranexamic acid (TXA) in normal saline (50cc) given over 15 minutes starting just prior to skin incision, and repeated 4 hours later
干预措施: Tranexamic Acid 100Mg/Ml Inj Vil 10Ml (Drug)
结局指标
主要结局
Intraoperative bleeding
时间窗: Surgical time
Subjective measure of intraoperative blood loss (mild, moderate, or severe)
Postoperative ecchymosis
时间窗: Postoperative day 9
Subjective measure of bruising rated as mild, moderate, or severe
Postoperative edema
时间窗: Postoperative day 9
Subjective measure of swelling rated as mild, moderate, or severe
次要结局
- Postoperative hematoma/seroma(10 days postoperative)
- Complications(10 days postoperative)