NCT06290193

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for phase_2 ovarian-cancer

Timeline
31mo left

Started Feb 2024

Typical duration for phase_2 ovarian-cancer

Geographic Reach
1 country

7 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress49%
Feb 2024Feb 2029

Study Start

First participant enrolled

February 23, 2024

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

February 26, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 4, 2024

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 23, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 23, 2029

Last Updated

April 1, 2026

Status Verified

March 1, 2026

Enrollment Period

5 years

First QC Date

February 26, 2024

Last Update Submit

March 31, 2026

Conditions

Ovarian CancerFallopian Tube CarcinomaOvarian CarcinomaPeritoneal CarcinomaOvarian Cancer Stage IIICFallopian Tube Cancer Stage IIICOvarian Cancer Stage IVFallopian Tube Cancer Stage IVFallopian Tube CancerPeritoneal Cancer

Keywords

ovarian cancerovarian carcinomaovarian cancer stage IIICovarian cancer stage IVfallopian tube cancerfallopian tube carcinomafallopian tube cancer stage IIICfallopian tube cancer stage IVperitoneal cancerperitoneal carcinomaAcute Normovolemic HemodilutionMemorial Sloan Kettering Cancer Center23-392

Outcome Measures

Primary Outcomes (1)

  • Comparison of the rate of allogenic red blood cell transfusions between the Acute Normovolemic Hemodilution (ANH) and standard of care arm

    The primary objective of this study is to determine if ANH reduces the requirement for allogenic red cell transfusions in patients undergoing primary cytoreductive surgery for ovarian cancer.

    up to 30 days from procedure

Study Arms (2)

Acute Normovolemic Hemodilution (ANH) Arm

EXPERIMENTAL
Biological: Acute Normovolemic Hemodilution/ANH

Standard Intraoperative Management Arm

NO INTERVENTION

Interventions

Acute Normovolemic Hemodilution/ANHBIOLOGICAL

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.

Acute Normovolemic Hemodilution (ANH) Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Memoral Sloan Kettering at Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, 07920, United States

RECRUITING

Memorial Sloan Kettering Monmouth (Limited protocol activities)

Middletown, New Jersey, 07748, United States

RECRUITING

Memorial Sloan Kettering Bergen (Limited protocol activities)

Montvale, New Jersey, 07645, United States

RECRUITING

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

Commack, New York, 11725, United States

RECRUITING

Memorial Sloan Kettering Westchester (Limited protocol activities)

Harrison, New York, 10604, United States

RECRUITING

Memorial Sloan Kettering Cancer Center (All protocol activities)

New York, New York, 10065, United States

RECRUITING

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York, 11553, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Ovarian NeoplasmsFallopian Tube Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersFallopian Tube Diseases

Study Officials

  • Dennis Chi, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dennis Chi, MD

CONTACT

212-639-5016chid@mskcc.org

Ginger Gardner, MD

CONTACT

212-639-2375gardnerg@mskcc.org

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2024

First Posted

March 4, 2024

Study Start

February 23, 2024

Primary Completion (Estimated)

February 23, 2029

Study Completion (Estimated)

February 23, 2029

Last Updated

April 1, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Locations

US(7)