Study of Acute Normovolemic Hemodilution (ANH) in People With Ovarian Cancer Who Are Having Cytoreductive Surgery
NCT ID: NCT06290193
Last Updated: 2026-01-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
86 participants
INTERVENTIONAL
2024-02-23
2029-02-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Acute Normovolemic Hemodilution (ANH) Arm
Acute 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.
Standard Intraoperative Management Arm
No interventions assigned to this group
Interventions
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Acute 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.
Eligibility Criteria
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Inclusion Criteria
* 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
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)
18 Years
ALL
No
Sponsors
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Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Dennis Chi, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Dennis Chi, MD
Role: primary
Dennis Chi, MD
Role: primary
Dennis Chi, MD
Role: primary
Dennis Chi, MD
Role: primary
Dennis Chi, MD
Role: primary
Dennis Chi, MD
Role: primary
Dennis Chi, MD
Role: primary
Related Links
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Memorial Sloan Kettering Cancer Center
Other Identifiers
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23-392
Identifier Type: -
Identifier Source: org_study_id
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