Recruiting
Phase 2

ANH

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT06290193

Conditions

Ovarian Cancer

Fallopian Tube Carcinoma

Ovarian Carcinoma

Peritoneal Carcinoma

Ovarian Cancer Stage IIIC

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Acute Normovolemic Hemodilution/ANH

Study Details

Brief 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.

Conditions

Ovarian Cancer

Fallopian Tube Carcinoma

Ovarian Carcinoma

Peritoneal Carcinoma

Ovarian Cancer Stage IIIC

Study ID

NCT06290193

Start date

Feb 23, 2024

Status verified date

Mar, 2026

Completion date

Feb 23, 2029

Anticipated

Primary completion date

Feb 23, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 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 Criteria:

  • 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)

Study Design

Enrollment

86 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Acute Normovolemic Hemodilution (ANH) Arm

no intervention: Standard Intraoperative Management Arm

Interventions

Acute 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.

Primary outcome measure

  • Comparison of the rate of allogenic red blood cell transfusions between the Acute Normovolemic Hemodilution (ANH) and standard of care arm [ Time Frame: up to 30 days from procedure ]

Central Contacts and Locations

Central contacts

Dennis Chi, MD

212-639-5016chid@mskcc.org

Ginger Gardner, MD

212-639-2375gardnerg@mskcc.org

Locations

Memoral Sloan Kettering at Basking Ridge (Limited Protocol Activities)

Recruiting

Basking Ridge, New Jersey, United States, 07920

Contacts

Dennis Chi, MD

212-639-5016

Memorial Sloan Kettering Monmouth (Limited protocol activities)

Recruiting

Middletown, New Jersey, United States, 07748

Contacts

Dennis Chi, MD

212-639-5016

Memorial Sloan Kettering Bergen (Limited protocol activities)

Recruiting

Montvale, New Jersey, United States, 07645

Contacts

Dennis Chi, MD

212-639-5016

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

Recruiting

Commack, New York, United States, 11725

Contacts

Dennis Chi, MD

212-639-5016

Memorial Sloan Kettering Westchester (Limited protocol activities)

Recruiting

Harrison, New York, United States, 10604

Contacts

Dennis Chi, MD

212-639-5016

Memorial Sloan Kettering Cancer Center (All protocol activities)

Recruiting

New York, New York, United States, 10065

Contacts

Dennis Chi, MD

212-639-5016

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Recruiting

Uniondale, New York, United States, 11553

Contacts

Dennis Chi, MD

212-639-5016

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

Apr 1, 2026

Last verified

Mar, 2026

Keywords

  • ovarian cancer
  • ovarian carcinoma
  • ovarian cancer stage IIIC
  • ovarian cancer stage IV
  • fallopian tube cancer
  • fallopian tube carcinoma
  • fallopian tube cancer stage IIIC
  • fallopian tube cancer stage IV
  • peritoneal cancer
  • peritoneal carcinoma
  • Acute Normovolemic Hemodilution
  • Memorial Sloan Kettering Cancer Center
  • 23-392

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-04-01.