Pre- Vs Postoperative Thromboprophylaxis for Liver Resection - a Prospective, Multicenter, Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 1,012
- 试验地点
- 7
- 主要终点
- Venous thromboembolisms
研究概览
简要总结
Thromboprophylaxis for liver surgery can be commenced either preoperatively or postoperatively. Despite a clear trade-off between thrombosis and bleeding in liver surgery patients, there is no international consensus when thrombosis prophylaxis should be commenced in patients undergoing liver surgery. As far as we know, there are no prospective randomized trials in this field, and current guidelines are unfortunately based on very low quality evidence, that is, a few retrospective studies and expert opinion. Both American and European thromboprophylaxis guidelines for abdominal cancer surgery support the preoperative initiation of thromboprophylaxis, but these guidelines do not specifically address the increased bleeding risk associated with liver surgery. On the contrary, Dutch guidelines recommend postoperative thromboprophylaxis only, because of lack of evidence for preoperative thromboprophylaxis. Traditionally, many liver surgery units have been reluctant in using preoperative thromboprophylaxis due to the potentially increased risk of bleeding complications. Enhanced Recovery After Surgery (ERAS) Society Guidelines recommend preoperative thromboprophylaxis in liver surgery, but the guidelines provide no supporting evidence for this recommendation. Overall, the amount of evidence is scarce and somewhat contradictory in this clinically relevant field of thromboprophylaxis in liver surgery. The aim of this study is to compare pre- and postoperatively initiated thromboprophylaxis regimens in liver surgery in a randomized controlled trial.
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 (Care Provider, Investigator, Outcomes Assessor)
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
- •All patients undergoing liver resection
排除标准
- •Patient on anticoagulative medication (heparin, low-molecular weight heparin, warfarin, direct oral anticoagulants) during last month pre-surgery
- •Emergency operation (e.g. for trauma or infection)
- •Age < 18 years
- •Allergy or other contraindication to planned low-molecular weight heparin
- •Inability to give written informed consent
- •Liver resection not performed (removed from analyses after randomization)
研究组 & 干预措施
Preoperative thromboprophylaxis
Preoperatively initiated tromboprophylaxis
干预措施: enoxaparin or tinzaparin or dalteparin (Drug)
Postoperative thromboprophylaxis
Postoperatively initiated thromboprophylaxis
干预措施: No intervention (Drug)
结局指标
主要结局
Venous thromboembolisms
时间窗: within 30 days from liver resection
Number of patients with venous thromboembolism defined as either 1) symptomatic deep venous thromboembolism (includes all deep veins e.g. all extremities, portal vein, and superior mesenteric) diagnosed using ultrasound or computed tomography or magnetic resonance imaging, or in re-laparatomy/surgery, 2) pulmonary embolism diagnosed using computed tomography, magnetic resonance imaging, or lung perfusion imaging, or 3) death due to venous thromboembolism
次要结局
- Posthepatectomy haemorrhage(within 30 days from liver resection)
- Postoperative complications(within 30 days from liver resection)
- Length of postoperative hospital stay(within 30 days from liver resection)
- Blood transfusion(during and within 30 days from liver resection)
研究者
Ville Sallinen
Principal investigator
Helsinki University Central Hospital