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RecruitingInterventionalPhase 2

A Prospective Randomized Trial of Acute Normovolemic Hemodilution (ANH) in Patients Undergoing Cytoreductive Surgery for Ovarian Cancer

NCT ID: NCT06290193Sponsor: Memorial Sloan Kettering Cancer CenterLast updated: 2026-04-01

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.

Arms & 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.

Outcome measures

Primary

  • Comparison of the rate of allogenic red blood cell transfusions between the Acute Normovolemic Hemodilution (ANH) and standard of care arm

    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.

    Time frame: up to 30 days from procedure

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy 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 not be included Exclusion Criteria: * 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)

Study locations (7)

Memoral Sloan Kettering at Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, 07920

Recruiting
Dennis Chi, MD · Contact

Memorial Sloan Kettering Monmouth (Limited protocol activities)

Middletown, New Jersey, 07748

Recruiting
Dennis Chi, MD · Contact

Memorial Sloan Kettering Bergen (Limited protocol activities)

Montvale, New Jersey, 07645

Recruiting
Dennis Chi, MD · Contact

Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activities)

Commack, New York, 11725

Recruiting
Dennis Chi, MD · Contact

Memorial Sloan Kettering Westchester (Limited protocol activities)

Harrison, New York, 10604

Recruiting
Dennis Chi, MD · Contact

Memorial Sloan Kettering Cancer Center (All protocol activities)

New York, New York, 10065

Recruiting
Dennis Chi, MD · Contact

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York, 11553

Recruiting
Dennis Chi, MD · Contact