A Prospective Randomized Trial of Acute Normovolemic Hemodilution (ANH) in Patients Undergoing Cytoreductive Surgery for Ovarian Cancer
Memorial Sloan Kettering Cancer Center
Summary
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 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…
Interventions
- BiologicalAcute Normovolemic Hemodilution/ANH
For participants randomized to ANH, the volume of blood to be removed will be calculated using an established formula, based on preoperative hemoglobin, target hemoglobin after hemodilution, and the patient's estimated blood volume.
Locations (7)
- Memoral Sloan Kettering at Basking Ridge (Limited Protocol Activities)Basking Ridge, New Jersey
- Memorial Sloan Kettering Monmouth (Limited protocol activities)Middletown, New Jersey
- Memorial Sloan Kettering Bergen (Limited protocol activities)Montvale, New Jersey
- Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activities)Commack, New York
- Memorial Sloan Kettering Westchester (Limited protocol activities)Harrison, New York
- Memorial Sloan Kettering Cancer Center (All protocol activities)New York, New York