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

Last updated: March 31, 2026
Sponsor: Memorial Sloan Kettering Cancer Center
Overall Status: Active - Recruiting

Phase

2

Condition

Vaginal Cancer

Malignant Ascites

Peritoneal Cancer

Treatment

Acute Normovolemic Hemodilution/ANH

Clinical Study ID

NCT06290193
23-392
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

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 byCT 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 plannedprocedures o Note: Patients scheduled for only diagnostic laparoscopy should not beincluded

Exclusion

Exclusion Criteria:

  • A history of active coronary artery disease o Patients with a history of coronary artery disease will be eligible if they havehad a cardiac stress study showing no reversible ischemia and normal LV functionwithin 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 theabsence of biliary tract obstruction)

  • Preoperative autologous blood donation within last 30 days or plan to donateautologous blood prior to surgery

  • Refusal to accept allogenic or autologous blood transfusion

  • Patients scheduled for cytoreductive surgery with planned HyperthermicIntraperitoneal Chemotherapy (HIPEC)

Study Design

Total Participants: 86
Treatment Group(s): 1
Primary Treatment: Acute Normovolemic Hemodilution/ANH
Phase: 2
Study Start date:
February 23, 2024
Estimated Completion Date:
February 23, 2029

Connect with a study center

  • Memoral Sloan Kettering at Basking Ridge (Limited Protocol Activities)

    Basking Ridge, New Jersey 07920
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Monmouth (Limited protocol activities)

    Middletown, New Jersey 07748
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Bergen (Limited protocol activities)

    Montvale, New Jersey 07645
    United States

    Active - Recruiting

  • Memoral Sloan Kettering at Basking Ridge (Limited Protocol Activities)

    Basking Ridge 5095409, New Jersey 5101760 07920
    United States

    Site Not Available

  • Memorial Sloan Kettering Monmouth (Limited protocol activities)

    Middletown 5101170, New Jersey 5101760 07748
    United States

    Site Not Available

  • Memorial Sloan Kettering Bergen (Limited protocol activities)

    Montvale 5101361, New Jersey 5101760 07645
    United States

    Site Not Available

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

    Commack, New York 11725
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Westchester (Limited protocol activities)

    Harrison, New York 10604
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Cancer Center (All protocol activities)

    New York, New York 10065
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Nassau (Limited Protocol Activities)

    Uniondale, New York 11553
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Westchester (Limited protocol activities)

    West Harrison, New York 10604
    United States

    Site Not Available

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

    Commack 5113412, New York 5128638 11725
    United States

    Site Not Available

  • Memorial Sloan Kettering Westchester (Limited protocol activities)

    Harrison 5120095, New York 5128638 10604
    United States

    Site Not Available

  • Memorial Sloan Kettering Cancer Center (All protocol activities)

    New York 5128581, New York 5128638 10065
    United States

    Site Not Available

  • Memorial Sloan Kettering Nassau (Limited Protocol Activities)

    Uniondale 5141927, New York 5128638 11553
    United States

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.