Serum Concentration of Tranexamic Acid After Topical Administration in Massive Weight Loss Skin Reducing Surgery
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Serum concentration of tranexamic acid
研究概览
简要总结
Tranexamic acid is a drug that prevents clotted blood from dissolving and hence reduces bleeding. It is routinely given intravenously in many surgical situations where there is a risk of major bleeding. Concerns regarding possible adverse effects from intravenous use prevents a more widespread use, even in smaller surgeries. Topical application - using the drug directly on the wound surface- may give a higher concentration at the site of bleeding but a lower concentration in the rest of the body, and hence a lower risk of adverse effects. Here it will be investigated to what extent a defined dose of the drug is absorbed systemically - into the blood stream - when it is applied topically. This will then be compared to the concentration in the blood stream when administered intravenously. Blood samples will be obtained at defined time intervals after administration from patients receiving topical and patients receiving intravenous administration of the same single dose of tranexamic acid. Will less of the drug enter the blood stream if it is applied directly to the wound?
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •planned for major skin reduction surgery (abdominoplasty/panniculectomy) after massive weight loss, or
- •planned for orthopaedic hip replacement surgery
排除标准
- •pregnancy
- •breastfeeding
- •known allergy to tranexamic acid/Cyklokapron®
- •ongoing or former thromboembolic event
- •known kidney failure, as defined by estimated glomerular filtration rate (eGFR)<60 ml/min
研究组 & 干预措施
abdominoplasty moistening
Tranexamic Acid 25 mg/ml for wound surface moistening prior to wound closure
干预措施: Tranexamic Acid 25 mg/ml for wound surface moistening (Drug)
abdominoplasty bolus
Tranexamic Acid 5 mg/ml as bolus in wound cavity after wound closure
干预措施: Tranexamic Acid 5 mg/ml as bolus in wound cavity (Drug)
preoperative intravenous administration
Tranexamic Acid Injectable Solution administered before hip replacement surgery
干预措施: Tranexamic Acid Injectable Solution (Drug)
结局指标
主要结局
Serum concentration of tranexamic acid
时间窗: 24 hours
as described by the Area Under the (time-concentration) Curve (AUC) from 0 to infinity, alternatively from 0 to 240 minutes if drug levels after 24 hours do not allow for such extrapolation
次要结局
- Timepoint for maximum serum concentration (Tmax)(24 hours)
- AUC from 0 to 240 min(24 hours)
- Maximum concentration (Cmax)(24 hours)
- Elimination half-life(24 hours)
- Adverse events(1 day)
