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NCT Number: NCT06290193

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

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.

Recruiting

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Acute Normovolemic Hemodilution/ANH

Biological

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 outcomes

  1. 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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Dennis Chi, MD

CONTACT

[email protected]

212-639-5016

Ginger Gardner, MD

CONTACT

[email protected]

212-639-2375

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Mar 4, 2024
Registry last updated
Apr 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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