Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06290193

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

Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-04-01

86

Participants Needed

7

Research Sites

261 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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)

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 7 locations

1

Memoral Sloan Kettering at Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, United States, 07920

Actively Recruiting

2

Memorial Sloan Kettering Monmouth (Limited protocol activities)

Middletown, New Jersey, United States, 07748

Actively Recruiting

3

Memorial Sloan Kettering Bergen (Limited protocol activities)

Montvale, New Jersey, United States, 07645

Actively Recruiting

4

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

Commack, New York, United States, 11725

Actively Recruiting

5

Memorial Sloan Kettering Westchester (Limited protocol activities)

Harrison, New York, United States, 10604

Actively Recruiting

6

Memorial Sloan Kettering Cancer Center (All protocol activities)

New York, New York, United States, 10065

Actively Recruiting

7

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York, United States, 11553

Actively Recruiting

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Research Team

D

Dennis Chi, MD

CONTACT

G

Ginger Gardner, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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