Study of Acute Normovolemic Hemodilution (ANH) in People With Ovarian Cancer Who Are Having Cytoreductive Surgery
A Prospective Randomized Trial of Acute Normovolemic Hemodilution (ANH) in Patients Undergoing Cytoreductive Surgery for Ovarian Cancer
Memorial Sloan Kettering Cancer Center
86 participants
Feb 23, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria6
- 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 only diagnostic laparoscopy should not be included
Exclusion Criteria13
- 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
- Patients scheduled for cytoreductive surgery with planned Hyperthermic Intraperitoneal Chemotherapy (HIPEC)
Interventions
For participants randomized to ANH, the volume of blood to be removed will be calculated using an established formula, based on preoperative hemoglobin, target hemoglobin after hemodilution, and the patient's estimated blood volume.
Locations(7)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06290193