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NCT06290193RecruitingPhase 2

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

Source: ClinicalTrials.gov · Last updated 1 Apr 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
86 (estimated)
First submitted
26 Feb 2024
Start date
23 Feb 2024
Primary completion date
23 Feb 2029
Lead sponsor
Memorial Sloan Kettering Cancer Center
NCT number
NCT06290193

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 86
  • From 23 Feb 2024 to the primary completion date, 23 Feb 2029
  • 7 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Preoperative autologous blood donation within last 30 days or plan to donate autologous blood prior to surgery
  • Patients scheduled for cytoreductive surgery with planned Hyperthermic Intraperitoneal Chemotherapy (HIPEC)

Other illness

  • 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
  • Presence of active infection

Lab values

  • 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)
  • Evidence of hepatic metabolic disorder (bilirubin \>2 mg/dl, ALT \>75 U/L in the absence of biliary tract obstruction)

Other

  • Refusal to accept allogenic or autologous blood transfusion

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (7)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Memoral Sloan Kettering at Basking Ridge (Limited Protocol Activities)
Coordinator of this site? Confirm its status
Basking RidgeUnited StatesRecruiting
Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited Protocol Activities)
Coordinator of this site? Confirm its status
CommackUnited StatesRecruiting
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Coordinator of this site? Confirm its status
HarrisonUnited StatesRecruiting
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Coordinator of this site? Confirm its status
MiddletownUnited StatesRecruiting
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Coordinator of this site? Confirm its status
MontvaleUnited StatesRecruiting
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
Coordinator of this site? Confirm its status
New YorkUnited StatesRecruiting
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Coordinator of this site? Confirm its status
UniondaleUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.