Preoperative Hexakapron Reduces Bleeding in Bariatric Surgery
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 152
- 试验地点
- 1
- 主要终点
- Treatment efficiency (lowering/preventing clinically significant bleeding)
研究概览
简要总结
Prophylactic use of tranexamic acid to reduce intra and postoperative bleeding in primary sleeve gastrectomy procedures will be studied.
详细描述
Patients scheduled for primary laparoscopic sleeve gastrectomy for the treatment of morbid obesity will be assigned to receive tranexamic acid vs. placebo before surgery. Intraoperative bleeding will be scored, as well as postoperative bleeding and blood or blood-product requirements. POstoperative venous thromboembolic events will be recorded up to 2 months following surgery.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Morbid obesity
- •Approved and scheduled for laparoscopic sleeve gastrectomy
排除标准
- •Previous bariatric surgery
- •Platelet count under 100,000
- •Concurrent anticoagulation treatment
- •Previous venous/atrerial thromboembolic event
- •Known allergy to tranexamic acid
- •History of heparin induced thrombocytopenia
- •Oral contraceptive use
- •Female hormonal replacement therapy
- •Active thromboembolic state
- •Genetic hypercoagulable state
研究组 & 干预措施
Treatment arm
Preoperative intravenous administration of 2g tranexamic acid in 10ml fluid.
干预措施: tranexamic acid (Drug)
Control Arm
Preoperative intravenous administration of 10ml normal saline.
干预措施: Placebo (Drug)
结局指标
主要结局
Treatment efficiency (lowering/preventing clinically significant bleeding)
时间窗: 1 week
The efficiency of preoperative tranexamic acid administration in lowering/preventing clinically significant bleeding.
Treatment safety (administering tranexamic acid preoperatively without promoting thromboembolic events)
时间窗: 2 months
The safety of administering tranexamic acid preoperatively without promoting thromboembolic events
次要结局
- Need for reintervention(1 week)
- Procedure change(1 day)
- Blood/blood product requirement(1 week)
研究者
David Goitein MD
Head, Bariatric and Metabolic Surgery
Sheba Medical Center