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

Description

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, Fallopian Tube Cancer Stage IIIC, Ovarian Cancer Stage IV, Fallopian Tube Cancer Stage IV, Fallopian Tube Cancer, Peritoneal Cancer

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Study Overview

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Study Details

Study 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.

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

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

Condition
Ovarian Cancer
Intervention / Treatment

-

Contacts and Locations

Basking Ridge

Memoral Sloan Kettering at Basking Ridge (Limited Protocol Activities), Basking Ridge, New Jersey, United States, 07920

Middletown

Memorial Sloan Kettering Monmouth (Limited protocol activities), Middletown, New Jersey, United States, 07748

Montvale

Memorial Sloan Kettering Bergen (Limited protocol activities), Montvale, New Jersey, United States, 07645

Commack

Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activities), Commack, New York, United States, 11725

New York

Memorial Sloan Kettering Cancer Center (All protocol activities), New York, New York, United States, 10065

Uniondale

Memorial Sloan Kettering Nassau (Limited Protocol Activities), Uniondale, New York, United States, 11553

West Harrison

Memorial Sloan Kettering Westchester (Limited protocol activities), West Harrison, New York, United States, 10604

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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 diagnostic laparoscopy should not be included
  • * A history of active coronary artery disease
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Memorial Sloan Kettering Cancer Center,

Dennis Chi, MD, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

Study Record Dates

2029-02-23