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Recruiting NCT06290193

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

Phase II Interventional Ovarian Cancer Fallopian Tube Carcinoma Ovarian Carcinoma Peritoneal Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Acute Normovolemic Hemodilution/ANH.
Who it may be relevant to
Registry conditions: Ovarian Cancer, Fallopian Tube Carcinoma, Ovarian Carcinoma, Peritoneal Carcinoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Prospective Randomized Trial of Acute Normovolemic Hemodilution (ANH) in Patients Undergoing Cytoreductive Surgery for Ovarian Cancer

Overview

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.

Interventions

  • Biological 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 measures

  • 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]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 7 centers
  • Memoral Sloan Kettering at Basking Ridge (Limited Protocol Activities) — Basking Ridge
  • Memorial Sloan Kettering Monmouth (Limited protocol activities) — Middletown
  • Memorial Sloan Kettering Bergen (Limited protocol activities) — Montvale
  • Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activities) — Commack
  • Memorial Sloan Kettering Westchester (Limited protocol activities) — Harrison
  • Memorial Sloan Kettering Cancer Center (All protocol activities) — New York
  • Memorial Sloan Kettering Nassau (Limited Protocol Activities) — Uniondale

Identifiers

NCT: NCT06290193 · 23-392

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗