RECRUITING

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

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Conditions

Ovarian CancerFallopian Tube CarcinomaOvarian CarcinomaPeritoneal CarcinomaOvarian Cancer Stage IIICFallopian Tube Cancer Stage IIICOvarian Cancer Stage IVFallopian Tube Cancer Stage IVFallopian Tube CancerPeritoneal CancerAcute Normovolemic HemodilutionMemorial Sloan Kettering Cancer Center23-392

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-02-23
Study Completion:2029-02-23
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06290193

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adults (≥18 years)
  2. * BLOODS score ≥2 as calculated by surgeon
  3. * 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
  4. * Planned for exploratory laparotomy and primary or interval cytoreductive surgery
  5. * Preoperative hemoglobin concentration ≥10 mg/dl within 45 days of surgery
  6. * Patients scheduled for cytoreductive surgery, with or without other planned procedures o Note: Patients scheduled for diagnostic laparoscopy should not be included
  1. * A history of active coronary artery disease
  2. * A history of cerebrovascular disease
  3. * A history of congestive heart failure
  4. * A history of uncontrolled hypertension
  5. * A history of restrictive or obstructive pulmonary disease
  6. * A history of renal dysfunction (Cr \>1.6 mg/dl)
  7. * Abnormal coagulation parameters (INR \>1.5 not on coumadin, or platelet count \<100,000 mcL)
  8. * Presence of active infection
  9. * Evidence of hepatic metabolic disorder (bilirubin \>2 mg/dl, ALT \>75 U/L in the absence of biliary tract obstruction)
  10. * Preoperative autologous blood donation within last 30 days or plan to donate autologous blood prior to surgery
  11. * Refusal to accept allogenic or autologous blood transfusion

Contacts and Locations

Study Contact

Dennis Chi, MD
CONTACT
212-639-5016
chid@mskcc.org
Ginger Gardner, MD
CONTACT
212-639-2375
gardnerg@mskcc.org

Principal Investigator

Dennis Chi, MD
PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center

Study Locations (Sites)

Memoral Sloan Kettering at Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920
United States
Memorial Sloan Kettering Monmouth (Limited protocol activities)
Middletown, New Jersey, 07748
United States
Memorial Sloan Kettering Bergen (Limited protocol activities)
Montvale, New Jersey, 07645
United States
Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activities)
Commack, New York, 11725
United States
Memorial Sloan Kettering Cancer Center (All protocol activities)
New York, New York, 10065
United States
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, 11553
United States
Memorial Sloan Kettering Westchester (Limited protocol activities)
West Harrison, New York, 10604
United States

Collaborators and Investigators

Sponsor: Memorial Sloan Kettering Cancer Center

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-23
Study Completion Date2029-02-23

Study Record Updates

Study Start Date2024-02-23
Study Completion Date2029-02-23

Terms related to this study

Keywords Provided by Researchers

  • 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

Additional Relevant MeSH Terms

  • 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