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Study of Acute Normovolemic Hemodilution (ANH) for Ovarian Cancer Surgery

This study is looking at whether a procedure called Acute Normovolemic Hemodilution (ANH) can reduce the need for blood transfusions during surgery for ovarian, fallopian tube, or peritoneal cancer. ANH involves removing some of your blood before surgery and giving it back later. You might be able to join if you are an adult (18 or older) with advanced ovarian, fallopian tube, or peritoneal cancer (stage IIIC or IV) and are planning to have surgery to remove tumors. The main goal is to see if people who receive ANH need fewer blood transfusions compared to those who receive standard care. The study aims to enroll 86 participants, but its current status is unclear.

Study design
This is an interventional study where participants will be randomly assigned to receive either Acute Normovolemic Hemodilution (ANH) or standard surgical management. It plans to enroll 86 participants.
What's involved
Participants will undergo primary cytoreductive surgery as part of their standard care, with either ANH or standard management during the surgery.
Compensation
Not stated in the trial record.
Follow-up
The need for allogenic red blood cell transfusions will be measured for up to 30 days from the procedure.

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NCT06290193

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Memorial Sloan Kettering Cancer Center
~86 participants
Updated 2026-04-01 on ClinicalTrials.gov
What's tested:Acute Normovolemic Hemodilution/ANH

At a glance

Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Comparison of the rate of allogenic red blood cell transfusions between the Acute Normovolemic Hemodilution (ANH) and standard of care arm
Measured over up to 30 days from procedure

Conditions

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

Explore related trials

Fallopian Tube CarcinomaMalignant Ovarian NeoplasmPeritoneal Carcinomatosis

Where it's being run

7 sites across 2 states
New York4
New Jersey3

Study leadership

  • Dennis Chi, MD · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer Center

Who to contact

Dennis Chi, MD
[email protected]
212-639-5016
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

A history of active coronary artery disease
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)

What this trial measures

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