Pre- Vs. Postoperative Thromboprophylaxis in Pancreatic Surgery - a Prospective, Multicenter, Randomized Controlled Trial (PREPOSTEROUS Pancreas Trial)
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 800
- 试验地点
- 5
- 主要终点
- Venous thromboembolism, number of patients
研究概览
简要总结
Thromboprophylaxis for pancreatic surgery can be commenced either preoperatively or postoperatively. Despite a clear trade-off between thrombosis and bleeding in pancreatic surgery patients, there is no international consensus when thrombosis prophylaxis should be commenced in patients undergoing pancreatic surgery. 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 pancreatic surgery. On the contrary, Dutch guidelines recommend postoperative thromboprophylaxis only, because of lack of evidence for preoperative thromboprophylaxis. Enhanced Recovery After Surgery (ERAS) Society Guidelines recommend preoperative thromboprophylaxis in pancreatic 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 pancreatic surgery. The aim of this study is to compare pre- and postoperatively initiated thromboprophylaxis regimens in pancreatic 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 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients undergoing either
- •pancreaticoduodenectomy or total pancreatectomy (for any indication) or
- •distal pancreatectomy for suspicion of cancer
排除标准
- •Patient on anticoagulative medication (heparin, low-molecular weight heparin, warfarin, direct oral anticoagulants) during the month (30 days) preceding surgery
- •Emergency operation (e.g. for trauma, infection or pancreatitis)
- •Age < 18 years
- •Allergy or other contraindication to planned low-molecular weight heparin
- •Inability to give written informed consent
- •Pancreatic 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/tinzaparin/dalteparin (Drug)
结局指标
主要结局
Venous thromboembolism, number of patients
时间窗: within 30 days from pancreatic resection
Number of patients that have venous thromboembolism, which include any of the following: 1) symptomatic deep venous thromboembolism (including all deep veins e.g. all extremities, portal-, and superior mesenteric vein) diagnosed using ultrasound or computed tomography or magnetic resonance imaging, or in re-laparotomy/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
- Postpancreatectomy hemorrhage (PPH)(within 30 days from pancreatic resection)
- Comprehensive Complication Index - score(within 30 days from pancreatic resection)
- Length of postoperative hospital stay,(within 30 days from pancreatic resection)
- Transfused red blood cells(during and within 30 days from pancreas resection)
- Post-operative hemoglobin below 70 g/l(during and within 30 days from pancreas resection)
研究者
Ville Sallinen
Primary investigator
Helsinki University Central Hospital