A Prospective Randomized Trial of Acute Normovolemic Hemodilution (ANH) in Patients Undergoing Cytoreductive Surgery for Ovarian Cancer
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 86
- 试验地点
- 7
- 主要终点
- Comparison of the rate of allogenic red blood cell transfusions between the Acute Normovolemic Hemodilution (ANH) and standard of care arm
研究概览
简要总结
Participants will be scheduled for primary cytoreductive surgery as part of their standard care. Before surgery, participants will be assigned by chance to a study group. Depending on which group they are in, they will receive either acute normovolemic hemodilution/ANH during surgery or standard surgical management during surgery. The researchers think acute normovolemic hemodilution/ANH may decrease the need for allogenic blood transfusion/ABT in people having primary cytoreductive 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
- None
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
- •Adults (≥18 years)
- •BLOODS score ≥2 as calculated by surgeon
- •High preoperative suspicion (or diagnosis) of advanced primary epithelial ovarian, fallopian tube, or primary peritoneal carcinoma (stage IIIC or IV), as determined by CT or MRI of the abdomen/pelvis
- •Planned for exploratory laparotomy and primary or interval cytoreductive surgery
- •Preoperative hemoglobin concentration ≥10 mg/dl within 45 days of surgery
- •Patients scheduled for cytoreductive surgery, with or without other planned procedures o Note: Patients scheduled for only diagnostic laparoscopy should not be included
排除标准
- •A history of active coronary artery disease
- •o Patients with a history of coronary artery disease will be eligible if they have had a cardiac stress study showing no reversible ischemia and normal LV function within 45 days of surgery.
- •A history of cerebrovascular disease
- •A history of congestive heart failure
- •A history of uncontrolled hypertension
- •A history of restrictive or obstructive pulmonary disease
- •A history of renal dysfunction (Cr >1.6 mg/dl)
- •Abnormal coagulation parameters (INR >1.5 not on coumadin, or platelet count <100,000 mcL)
- •Presence of active infection
- •Evidence of hepatic metabolic disorder (bilirubin >2 mg/dl, ALT >75 U/L in the absence of biliary tract obstruction)
- •Preoperative autologous blood donation within last 30 days or plan to donate autologous blood prior to surgery
- •Refusal to accept allogenic or autologous blood transfusion
- •Patients scheduled for cytoreductive surgery with planned Hyperthermic Intraperitoneal Chemotherapy (HIPEC)
研究组 & 干预措施
Acute Normovolemic Hemodilution (ANH) Arm
干预措施: Acute Normovolemic Hemodilution/ANH (Biological)
结局指标
主要结局
Comparison of the rate of allogenic red blood cell transfusions between the Acute Normovolemic Hemodilution (ANH) and standard of care arm
时间窗: up to 30 days from procedure
The primary objective of this study is to determine if ANH reduces the requirement for allogenic red cell transfusions in patients undergoing primary cytoreductive surgery for ovarian cancer.
次要结局
未报告次要终点