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

Launched by MEMORIAL SLOAN KETTERING CANCER CENTER · Feb 26, 2024

Keywords

ClinConnect Summary

This clinical trial is researching a method called Acute Normovolemic Hemodilution (ANH) in patients with advanced ovarian cancer who are scheduled for surgery. The goal of the trial is to see if using ANH during surgery can help reduce the need for blood transfusions, which are sometimes necessary during major operations. Participants will be randomly assigned to either receive ANH or standard surgical care, allowing researchers to compare the outcomes of both groups.

To be eligible for this study, participants need to be adults aged 18 or older with a high suspicion of advanced ovarian or related cancers, and they must be planning to undergo a specific type of surgery called primary cytoreductive surgery. Some important health criteria include having a certain level of hemoglobin (a protein in red blood cells) and not having serious heart or lung issues. If you join the trial, you can expect close monitoring during surgery and follow-up to see how you respond to the treatment. This research could potentially lead to better surgical outcomes for patients with advanced ovarian cancer.

Gender

ALL

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 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