Ovarian Cancer Clinical Trial

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

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Adults (≥18 years)
BLOODS score ≥3 as calculated by surgeon
High preoperative suspicion 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 PCS
Preoperative hemoglobin concentration ≥10 mg/dl within 30 days of registration
Patients scheduled for PCS, with or without other planned procedures

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 30 days of operation.

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

Study is for people with:

Ovarian Cancer

Phase:

Phase 2

Estimated Enrollment:

86

Study ID:

NCT06290193

Recruitment Status:

Recruiting

Sponsor:

Memorial Sloan Kettering Cancer Center

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There are 7 Locations for this study

See Locations Near You

Memoral Sloan Kettering at Basking Ridge (Limited Protocol Activities)
Basking Ridge New Jersey, 07920, United States More Info
Dennis Chi, MD
Contact
212-639-5016
Memorial Sloan Kettering Monmouth (Limited protocol activities)
Middletown New Jersey, 07748, United States More Info
Dennis Chi, MD
Contact
212-639-5016
Memorial Sloan Kettering Bergen (Limited protocol activities)
Montvale New Jersey, 07645, United States More Info
Dennis Chi, MD
Contact
212-639-5016
Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activities)
Commack New York, 11725, United States More Info
Dennis Chi, MD
Contact
212-639-5016
Memorial Sloan Kettering Westchester (Limited protocol activities)
Harrison New York, 10604, United States More Info
Dennis Chi, MD
Contact
212-639-5016
Memorial Sloan Kettering Cancer Center (All protocol activities)
New York New York, 10065, United States More Info
Dennis Chi, MD
Contact
212-639-5016
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale New York, 11553, United States More Info
Dennis Chi, MD
Contact
212-639-5016

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 2

Estimated Enrollment:

86

Study ID:

NCT06290193

Recruitment Status:

Recruiting

Sponsor:


Memorial Sloan Kettering Cancer Center

How clear is this clinincal trial information?

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