Fallopian Tube Cancer, Fallopian Tube Cancer Stage IIIC, Fallopian Tube Cancer Stage IV, Fallopian Tube Carcinoma, Ovarian Cancer, Ovarian Cancer Stage IIIC, Ovarian Cancer Stage IV, Ovarian Carcinoma, Peritoneal Cancer, Peritoneal Carcinoma
Conditions
Keywords
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
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.
Interventions
BIOLOGICALAcute Normovolemic Hemodilution/ANH
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.
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 only 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 * Patients scheduled for cytoreductive surgery with planned Hyperthermic Intraperitoneal Chemotherapy (HIPEC)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
CONTACTDennis Chi, MD
CONTACTGinger Gardner, MD
PRINCIPAL_INVESTIGATORDennis Chi, MD
Memorial Sloan Kettering Cancer Center
Outcome results
None listed