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Acute Normovolemic Hemodilution in Patients Undergoing Cytoreductive Surgery for Advanced Ovarian Cancer
Trial Status: active
This phase II trial studies how well acute normovolemic hemodilution (ANH) works in patients undergoing cytoreductive surgery for with ovarian, fallopian tube, or primary peritoneal cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Patients who have cytoreductive surgery are at a high risk of blood loss, and they commonly need an allogenic blood transfusion (ABT) to replace that blood. ABT is a procedure in which blood from a donor is given through a vein. Cytoreductive surgery is a surgical procedure that refers to the removal of as many cancer cells as possible from an anatomic site affected by cancer. ANH is a process in which blood is collected from a patient during a surgery that is likely to cause blood loss. The collected blood is replaced with other fluids. The blood is then stored during the surgery and given back when needed, usually due to bleeding during surgery, or at the end of surgery. Researchers think ANH may decrease the need for ABT in patients with advanced ovarian cancer having cytoreductive surgery.
Inclusion Criteria
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 computed tomography (CT) or magnetic resonance imaging (MRI) of the abdomen/pelvis
Planned for exploratory laparotomy and primary or interval cytoreductive surgery
Preoperative hemoglobin concentration >= 10 g/dl within 45 days of surgery
Patients scheduled for cytoreductive surgery, with or without other planned procedures
* Note: Patients scheduled for diagnostic laparoscopy should not be included
Exclusion Criteria
A history of active coronary artery disease
* 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 left ventricle (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 (Creatinine [Cr] > 1.6 mg/dl)
Abnormal coagulation parameter (International normalized ratio [INR] > 1.5 not on coumadin)
I. To determine if ANH reduces the requirement for allogenic red cell transfusions in patients undergoing cytoreductive surgery for ovarian cancer.
SECONDARY OBJECTIVE:
I. To determine the impact of ANH on the rate of transfusion of other blood products such as fresh frozen plasma (FFP), platelets, and cryoprecipitate, intraoperative management, post-operative complications, length of hospital stay, and operating time compared to standard intraoperative management.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo standard of care (SOC) cytoreductive surgery and undergo ANH comprising of the removal of whole blood followed by an infusion of crystalloid and colloidal solution. Patients may undergo autologous blood transfusion during surgery (if hemoglobin < 6 g/dL) or after completion of surgery. Patients also undergo chest x-ray or chest computed tomography (CT) during screening.
ARM II: Patients undergo SOC cytoreductive surgery on study. Patients may undergo autologous blood transfusion during surgery (if hemoglobin < 6 g/dL) or after completion of surgery. Patients also undergo chest x-ray or chest CT during screening.
After completion of study intervention, patients are followed up at 30 days.
Trial PhasePhase II
Trial Typetreatment
Lead OrganizationMemorial Sloan Kettering Cancer Center
