Study of Acute Normovolemic Hemodilution (ANH) in People With Ovarian Cancer Who Are Having Cytoreductive Surgery

Recruiting now · Phase 2

Conditions studied: Ovarian Cancer, Fallopian Tube Carcinoma, Ovarian Carcinoma, Peritoneal Carcinoma, Ovarian Cancer Stage IIIC, Fallopian Tube Cancer Stage IIIC, Ovarian Cancer Stage IV, Fallopian Tube Cancer Stage IV, Fallopian Tube Cancer, Peritoneal Cancer

In brief

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.

Key facts

Study ID

NCT06290193

Run by

Memorial Sloan Kettering Cancer Center

People needed

86

Starts

2024-02-23

Expected to finish

2029-02-23

Last updated by the study team

2026-04-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Memoral Sloan Kettering at Basking Ridge (Limited Protocol Activities) — Basking Ridge, New Jersey, United States (enrolling)
• Memorial Sloan Kettering Monmouth (Limited protocol activities) — Middletown, New Jersey, United States (enrolling)
• Memorial Sloan Kettering Bergen (Limited protocol activities) — Montvale, New Jersey, United States (enrolling)
• Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activities) — Commack, New York, United States (enrolling)
• Memorial Sloan Kettering Westchester (Limited protocol activities) — Harrison, New York, United States (enrolling)
• Memorial Sloan Kettering Cancer Center (All protocol activities) — New York, New York, United States (enrolling)
• Memorial Sloan Kettering Nassau (Limited Protocol Activities) — Uniondale, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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