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

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Enrolling; Phase 2

Conditions: Ovarian Cancer Stage IIIC; Ovarian Cancer Stage IV; Peritoneal Cancer; Ovarian Carcinoma; Fallopian Tube Cancer; Fallopian Tube Cancer Stage IIIC; Ovarian Cancer; Fallopian Tube Cancer Stage IV; Fallopian Tube Carcinoma; Peritoneal Carcinoma

Treatments: Biological: Acute Normovolemic Hemodilution/ANH

Study type: Interventional

Funder types: Other

Identifiers

NCT06290193

23-392

Details and patient eligibility

About

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.

Enrollment: 86 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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86 participants in 2 patient groups

Acute Normovolemic Hemodilution (ANH) Arm

Experimental group

Treatment:

Biological: Acute Normovolemic Hemodilution/ANH

Standard Intraoperative Management Arm

No Intervention group