Clinical trial NCT06290193: Study of Acute Normovolemic Hemodilution (ANH) in People With Ovarian Cancer Who Are Having Cytoreductive Surgery
Official title: A Prospective Randomized Trial of Acute Normovolemic Hemodilution (ANH) in Patients Undergoing Cytoreductive Surgery for Ovarian Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Ovarian Cancer
Fallopian Tube Carcinoma
Ovarian Carcinoma
Peritoneal Carcinoma
Ovarian Cancer Stage IIIC
Fallopian Tube Cancer Stage IIIC
Ovarian Cancer Stage IV
Fallopian Tube Cancer Stage IV
Fallopian Tube Cancer
Peritoneal Cancer
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
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2024-03-04
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Comparison of the rate of allogenic red blood cell transfusions between the Acute Normovolemic Hemodilution (ANH) and standard of care arm
timeFrame: up to 30 days from procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memoral Sloan Kettering at Basking Ridge (Limited Protocol Activities)
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth (Limited protocol activities)
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen (Limited protocol activities)
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activities)
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester (Limited protocol activities)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center (All protocol activities)
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Nassau (Limited Protocol Activities)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Dennis Chi, MD
role: PRINCIPAL_INVESTIGATOR
References: