RecruitingPhase 2NCT06290193

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

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


Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

86 participants

Start Date

Feb 23, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a blood conservation technique called acute normovolemic hemodilution (ANH) during surgery for advanced ovarian cancer. ANH involves temporarily removing some of the patient's blood before surgery and replacing it with fluids, then returning the blood during or after surgery to reduce the need for donated blood transfusions. **You may be eligible if...** - You are 18 or older with suspected or confirmed advanced ovarian, fallopian tube, or peritoneal cancer (stage IIIC or IV) - You are scheduled for exploratory abdominal surgery and tumor-removal surgery - Your hemoglobin (a measure of red blood cells) is at least 10 mg/dL within 45 days before surgery - Your surgeon has assessed you as suitable based on a specific scoring system (BLOODS score ≥2) **You may NOT be eligible if...** - You have active heart disease (such as coronary artery disease without a recent normal stress test) - You are scheduled only for diagnostic laparoscopy (not full surgery) - You have other conditions that make blood removal unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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, United States

Memorial Sloan Kettering Monmouth (Limited protocol activities)

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen (Limited protocol activities)

Montvale, New Jersey, United States

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

Commack, New York, United States

Memorial Sloan Kettering Westchester (Limited protocol activities)

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center (All protocol activities)

New York, New York, United States

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York, United States

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NCT06290193


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