Assessment of the Impact of Perioperative Administration of Tranexamic Acid on Bleeding After Sleeve Gastrectomy - a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Blood loss.
研究概览
简要总结
Enhanced recovery after bariatric surgery imposes a significant reduction in length of hospital stay. However beneficial for the overall recovery it reduces the hospital observation time. after a laparoscopic surgery during which one of the longest resection line in surgery or anastomosis are created. Therefore, discovering possible safe and effective ways of pharmacologically reducing surgical blood loss and reducing the risk of postoperative bleeding would be an invaluable addition to the protocol. The systemic use of tranexamic acid (TXA) has been shown to be effective in many types of surgery, reducing the incidence of post-operative bleeding and thereby reducing the rate of reoperation.
详细描述
Aim:
To evaluate if TXA systemic administration reduces postoperative blood loss in bariatric surgeriessleeve gastrectomy operation.
Material and methods:
A single-blind randomized clinical trial in the high-volume bariatric center of excellence.
Patients undergoing highly standardized bariatric procedures, meeting the inclusion and exclusion criteria were included in the study, sample size determined by power study evaluation.
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
- Single (Investigator)
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
- •Participant were adults qualified for bariatric procedure
排除标准
- •Primary (pre-operative) exclusion criteria were as follows:
- •Usage of anticoagulative agents in the perioperative period including:
- •Indirect thrombin inhibitors (Fondaparinux, UFH, LMWH in therapeutic dosing)
- •Direct inhibitors of factor Xa (NOAC)
- •Direct thrombin inhibitors (Dabigatran)
- •Vitamin K Antagonists (VKA: acenokumarol, warfarin)
- •Platelet aggregation inhibitors (excluding ASA in dosing 75mg per day)
- •P2Y12 receptor inhibitors
- •Prior diagnosis of congenital or acquired blood coagulation disorders
- •Diagnosed allergic reactions to TXA in medical history
- •Chronic Kidney Disease in stage G3 or higher
- •Chronic hemodialysis
- •Haematuria in medical history
- •Seizures in medical history
- •To achieve the most homogenous group of patients and to reduce possible bias due to additional interventions occurring during the operation - further, postoperative exclusion criteria were introduced:
- •Performed operation other than laparoscopic sleeve gastrectomy (LSG) Necessity of TXA administration in the postoperative period Additional, supplementary heamostatic materials and methods were used during the operation - deviation from the standard operation protocol such as: use of oxidized regenerative cellulose (ORC), cyanoacrylate laparoscopic bioglue (IfabondÒ, Peters Surgical), staple-line reinforcement.
研究组 & 干预措施
TXA group.
Administration of 1g tranexamic acid intravenous bolus, after anesthesia was introduced.
干预措施: Administration of 1g tranexamic acid intravenous bolus, after anesthesia was introduced (Drug)
结局指标
主要结局
Blood loss.
时间窗: First postoperative day.
Patients were evaluated on the postoperative day 1 by standard lab tests included in the center's protocol, additionally measuring the volume of drainage and heamoglobin concentration in the drainage sample.
次要结局
- TXA complications.(One month.)