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

Phase 2

Recruiting

• Conditions: Peritoneal Cancer; Ovarian Cancer; Fallopian Tube Carcinoma; Peritoneal Carcinoma; Fallopian Tube Cancer Stage IIIC; Fallopian Tube Cancer Stage IV; Ovarian Carcinoma; Ovarian Cancer Stage IIIC; Ovarian Cancer Stage IV; Fallopian Tube Cancer
• Interventions: Biological: Acute Normovolemic Hemodilution/ANH

• Registration Number: NCT06290193
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-23
• Study First Submitted: 2024-02-26
• Study First Submitted QC: 2024-02-26
• Study First Posted: 2024-03-04
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-19
• Last Update Posted: 2025-05-22
• Primary Completion: 2029-02-23
• Study Completion: 2029-02-23

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 86

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acute Normovolemic Hemodilution (ANH) Arm	Acute Normovolemic Hemodilution/ANH	-

Primary Outcome Measures

Name	Time	Method
Comparison of the rate of allogenic red blood cell transfusions between the Acute Normovolemic Hemodilution (ANH) and standard of care arm	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.

Trial Locations

Locations (7)

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

Memorial Sloan Kettering Monmouth (Limited protocol activities); 🇺🇸 Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen (Limited protocol activities); 🇺🇸 Montvale, New Jersey, United States

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

Memorial Sloan Kettering Westchester (Limited protocol activities); 🇺🇸 Harrison, New York, United States

Memorial Sloan Kettering Cancer Center (All protocol activities); 🇺🇸 New York, New York, United States

Memorial Sloan Kettering Nassau (Limited Protocol Activities); 🇺🇸 Uniondale, New York, United States