The Effect of Acute Normovolemic Hemodilution on Intraoperative Allogeneic Transfusion in Bone Tumor Surgery: a Prospective, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Intraoperative allogeneic red blood cell transfusion volume
研究概览
简要总结
The prevention of intraoperative allogenetic blood transfusion has the potential to reduce complications, hospital stays, and long-term prognosis in patients undergoing bone cancer surgery. Data from previous studies suggest that the clinical efficacy of acute normovolemic hemodilution (ANH) has always been controversial. The HEAL trial will assess whether ANH will reduce the volume of intraoperative allogeneic red blood cell transfusion in patients undergoing bone cancer surgery.
详细描述
Bone tumor surgery is associated with a significant risk of intraoperative blood loss and transfusion, with blood loss usually in the range of approximately 500-1000 ml and an average transfusion of up to 2 units of allogeneic red blood cell. The increase in allogeneic blood transfusion volume is an independent risk factor for postoperative complications in patients undergoing bone tumor surgery, as well as affecting the long-term survival rate of cancer patients.
Acute normovolemic hemodilution (ANH) is a patient blood management measure. The clinical efficacy of acute normovolemic hemodilution (ANH) has always been controversial. It is of great importance to explore the efficacy of ANH in bone cancer surgery patients.
Bone cancer surgery is an ideal setting to evaluate the efficacy of ANH, as the procedure is associated with high blood loss and infusion. The 'Hemodilution on intraoperative Allogeneic Transfusion' (HEAL) trial has been designed as a randomized, controlled trial to determine whether ANH will reduce the volume of intraoperative allogeneic red blood cell transfusion in patients undergoing bone cancer surgery.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18 to 75 years;
- •undergoing elective bone tumor resection surgery;
- •preoperative hemoglobin ≥11 g/dL;
排除标准
- •using a tourniquet;
- •palliative operation or minimally invasive surgery;
- •BMI<18.5 or >30Kg/m^2;
- •international normalized ratio (INR) >1.5 or platelet count <100 × 10^9/L;
- •cardiopulmonary insufficiency;
- •hepatic and renal dysfunction;
- •active infectious disease;
- •allergy to succinyl gelatin;
- •declined participation in the study or declined blood transfusion
研究组 & 干预措施
acute normovolemic hemodilution group (ANH group)
The ANH process was initiated after tracheal intubation. After completion of ANH, goal-directed fluid therapy will begin until the end of the surgery.
干预措施: acute normovolemic hemodilution (Procedure)
Standard Group (STD group)
After tracheal intubation, goal-directed fluid therapy will be implemented until the end of the surgery.
结局指标
主要结局
Intraoperative allogeneic red blood cell transfusion volume
时间窗: From the beginning to the end of the surgery
The volume of allogeneic red blood cell transfusions during the intraoperative period. Between-group comparisons were performed using student t tests for normally distributed data, and Wilcoxon rank-sum tests otherwise.
次要结局
- The blood loss during the perioperative period(From the start of surgery to discharge or the 7th day following the operation, which comes first)
- The intraoperative hemodynamic indexes(From the beginning to the end of the surgery)
- Perioperative embolic events(From the start of surgery to discharge or the 7th day following the operation, which comes first)
- Perioperative pulmonary infection(From the start of surgery to discharge or the 7th day following the operation, which comes first)
- The rate of perioperative transfusion of allogeneic blood products(From the start of surgery to discharge or the 7th day following the operation, which comes first)
- The volume of fluid administration during the intraoperative period(From the beginning to the end of the surgery)
- The coagulation function tests during the perioperative period(From the start of surgery to discharge or the 7th day following the operation, which comes first)
- Length of stay in hospital(Through study completion, an average of 1 year)
- Perioperative wound infection(From the start of surgery to discharge or the 7th day following the operation, which comes first)