the Use of Tranexamic Acid in Preventing Intraoperative and Postoperative Hemorrahge in Bariatric Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- intraoperative estimated blood loss (EBL
研究概览
简要总结
Our study aims at evaluating the role of tranexamic acid in bariatric surgery since, The effect of conservative therapy using tranexamic acid for postoperative hemorrhage after bariatric surgery is still very much a novel technique. However,Intravenous tranexamic acid at the time of laparoscopic sleeve gastrectomy is associated with a significant reduction of post-operative bleeding with no observed differences in thromboembolic events or mortality.
详细描述
Participants were randomized in a 1:1 ratio to receive tranexamic acid or placebo using a computer-generated block randomization sequence (block size = 4) prepared by an independent pharmacist. Allocation concealment was maintained with sequentially numbered, opaque, sealed envelopes. The pharmacist also prepared indistinguishable infusion bags containing either tranexamic acid (1 g diluted in 100 mL of 0.9% saline) or placebo (100 mL of 0.9% saline). The infusion was administered intravenously over 10-15 minutes immediately after induction of anesthesia and before skin incision, at a maximum rate of 100 mg per minute. Blinding was maintained for patients, anesthesiologists, scrub nurses, and all postoperative assessors, while the operating surgeon was necessarily unblinded, becoming aware of allocation only once the envelope was opened in the operating room. All analyses were performed according to the intention-to-treat principle.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Participants were randomized in a 1:1 ratio to receive tranexamic acid or placebo using a computer-generated block randomization sequence (block size = 4) prepared by an independent pharmacist. Allocation concealment was maintained with sequentially numbered, opaque, sealed envelopes. The pharmacist also prepared indistinguishable infusion bags containing either tranexamic acid (1 g diluted in 100 mL of 0.9% saline) or placebo (100 mL of 0.9% saline). The infusion was administered intravenously over 10-15 minutes immediately after induction of anesthesia and before skin incision, at a maximum rate of 100 mg per minute. Blinding was maintained for patients, anesthesiologists, scrub nurses, and all postoperative assessors, while the operating surgeon was necessarily unblinded, becoming aware of allocation only once the envelope was opened in the operating room. All analyses were performed according to the intention-to-treat principle.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18-60 years were eligible if they had a body mass index (BMI) ≥ 35 kg/m², or ≥ 30 kg/m² with at least one obesity-related diseases(type 2 diabetes, hypertension, or obstructive sleep apnea).
排除标准
- •Patients were excluded if they had a known coagulopathy or platelet disorder, a history of venous thromboembolism, myocardial infarction, or cerebrovascular accident, or if they on anticoagulant or antiplatelet therapy within ten days before surgery. Additional exclusion criteria included prior bariatric or major upper abdominal surgery, allergy or hypersensitivity to tranexamic acid, chronic kidney disease (stage 4-5), significant hepatic impairment, pregnancy or lactation.
- •Patient with alzheimer disease
研究组 & 干预措施
tranexamic acid (1 g diluted in 100 mL of 0.9% saline
TXA 1gm dilutedin 100 ml of .9% normal saline Will be given as IV infusion Before anasthesia
干预措施: tranexamic acid (1 g diluted in 100 mL of 0.9% saline (Drug)
placebo (100 mL of 0.9% saline).
Placebo diluted in 100 ml of .9% normal saline Will be given as IV infusion Before anasthesia
干预措施: placebo (100 mL of 0.9% saline). (Drug)
结局指标
主要结局
intraoperative estimated blood loss (EBL
时间窗: 10 DAYS
Volume of blood loss in cm centimeter cubic
BLEEDING IN SLEEVE GASTRECTOMY
时间窗: 10 DAYS
Volume of blood loss in cubic centimeter
次要结局
未报告次要终点
研究者
Mohammed Elshwadfy Nageeb
lecturer
Cairo University