PRICE 2: A Phase 3 Randomized Controlled Trial of Phlebotomy Resulting in Controlled Hypovolemia to Prevent Blood Loss in Major Hepatic Resections
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 440
- 试验地点
- 5
- 主要终点
- Packed Red Blood Cell Transfusion Rates
研究概览
简要总结
Major liver resection is associated with substantial intraoperative blood loss and subsequently blood transfusions. Blood transfusion in elective liver surgery is a significant factor of perioperative morbidity and mortality, as well as possibly long-term oncologic outcome. The purpose of this study is to use whole blood phlebotomy to decrease the central venous pressure, resulting in a state of relative hypovolemia. It is hypothesized that this intervention will lead to a decrease in blood loss at the time of liver resection and thus reduced blood transfusion in major liver surgeries.
详细描述
Major liver resection is associated with significant intraoperative blood loss and blood transfusions. Blood transfusion in elective liver surgery is a key determinant of perioperative morbidity and mortality, as well as possibly long-term oncologic outcome. Whole blood phlebotomy is a simple intervention, whose aim is to decrease the central venous pressure yielding a state of relative hypovolemia and thus lead to decreased blood loss and subsequently blood transfusion. Small studies, mostly from the liver transplant literature, would suggest that phlebotomy with controlled hypovolemia can result in decreased blood loss and blood transfusion. Since blood loss is an important issue in liver surgery, and the benefits of phlebotomy and controlled hypovolemia are unknown in liver resection patients, a rigorously conducted trial in a representative population of patients undergoing liver resection is warranted, and feasible. In this proposal, it is hypothesized that by the use of hypovolemic phlebotomy, it is possible to decrease blood loss and blood transfusions. To test this hypothesis the investigators plan to randomly allocate participants to hypovolemic phlebotomy plus standard of care or to standard of care. Participants will be those patients undergoing elective major liver resection at The Ottawa Hospital, le Centre Hospitalier de l'Université de Montréal, and le Centre Hospitalier de l'Université de Sherbrooke for any indication. The primary outcome will be red blood cells transfusion up to 30 days following surgery. Secondary outcomes will include intraoperative blood loss, other blood product transfusion requirements, perioperative morbidity and mortality, safety, physiologic parameters, and feasibility elements. A total of 440 patients will be randomized across the 3 sites in Ontario and Quebec. The efficacy of phlebotomy in terms of blood loss and transfusion prevention will be assessed.
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, 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
- •Adult patients (≥18 years)
- •projected to undergo a major liver resection (≥3 segments resected or partially resected), a right posterior sectionectomy (segments 6/7), or central resection (4b/5) for any indication, or the resection of 1 or more segments in a known cirrhotic patient.
排除标准
- •Age <18 years
- •Preoperative hemoglobin <100g/L
- •GFR clearance <60mL/min
- •Abnormal coagulation parameters (not on warfarin and/or platelets count <100 X10^9/L)
- •Evidence of hepatic metabolic disorder
- •Active cardiac conditions: Unstable coronary syndromes; Severe valvular disease; and Myocardial infarction within 6 months prior to surgery
- •History of significant cerebrovascular disease: Patients with clinically-significant stroke/CVA within the past 6 months or severe carotid stenosis (defined as >70%)
- •History of significant peripheral vascular disease: Non-revascularized with regular/ongoing claudication
- •Pregnancy
- •Refusal of blood products
- •Presence of active infection
- •Preoperative autologous blood donation
- •Planned intraoperative use of cell saver
结局指标
主要结局
Packed Red Blood Cell Transfusion Rates
时间窗: 30 days post-operation
Units of packed red blood cells transfused to participants
次要结局
- Blood product transfusion rates(Postoperative setting up to 30 days following surgery)
- Changes in physiologic parameters (Central Venous Pressure)(measured during surgery (intraoperatively))
- Intraoperative blood loss(up to 90 days before surgery; and on post-operative day 2)
- Perioperative morbidity and mortality(Postoperative setting up to 30 days following surgery)
- Changes in physiologic parameters (Pulse Pressure Variation)(measured during surgery (intraoperatively))