2024-513570-22-00招募中3 期
Peroperative Administration of Tranexamic acid in Roux-en-Y and one-anastomosis gastric bypass to reduce haemorrhage (PATRY study): a randomized controlled trial
Sint Franciscus Vlietland Groep Stichting6 个研究点 分布在 1 个国家目标入组 1,524 人开始时间: 2024年5月23日最近更新:
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 1,524
- 试验地点
- 6
- 主要终点
- Postoperative intervention due to haemorrhage (defined as: administration of packed red blood cells, surgical-, radiological-, or endoscopic intervention).
研究概览
简要总结
This trial aims to investigate whether peroperative administration of TXA reduces haemorrhage rates in patients who undergo gastric bypass surgery.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 years or older, eligible for bariatric surgery according to the IFSO guidelines and undergoing a laparoscopic (Roux-en-Y or one-anastomosis) gastric bypass.
排除标准
- •Patients unwilling to give informed consent, patients with a medical history of bleeding or venous thromboembolism and patients that use anticoagulants will be excluded.
结局指标
主要结局
Postoperative intervention due to haemorrhage (defined as: administration of packed red blood cells, surgical-, radiological-, or endoscopic intervention).
Postoperative intervention due to haemorrhage (defined as: administration of packed red blood cells, surgical-, radiological-, or endoscopic intervention).
次要结局
- Use hemostatic staple devices, amount of hemostatic staples, use of fibrin sealant, the amount of blood loss peroperatively, decrease in hemoglobin postoperatively, increase in heart rate postoperatively, hematemesis and/or melena, rates of postoperative hemorrhage (i.e. hemorrhage for which extra hemoglobin monitoring and/or administration of TXA and/or reinterventions), rates of VTE, other complications, hospitalization time, painscore, side effects of TXA, duration of primary surgery.
研究者
Mabel Kwakkelstein
Scientific
Sint Franciscus Vlietland Groep Stichting
研究点 (6)
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