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NCT06290193 Clinical Trial

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

Ovarian Cancer Clinical Trial

Official title:
A Prospective Randomized Trial of Acute Normovolemic Hemodilution (ANH) in Patients Undergoing Primary Cytoreductive Surgery for Ovarian Cancer

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06290193
Other study ID # 23-392
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date February 23, 2024
Est. completion date February 23, 2029

Study information
Verified date February 2024
Source Memorial Sloan Kettering Cancer Center
Contact Dennis Chi, MD
Phone 212-639-5016
Email chid@mskcc.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 86
Est. completion date February 23, 2029
Est. primary completion date February 23, 2029
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Biological:
• 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.

Locations
Country Name City State
United States Memoral Sloan Kettering at Basking Ridge (Limited Protocol Activities) Basking Ridge 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 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 (All protocol activities) New York New York
United States Memorial Sloan Kettering Nassau (Limited Protocol Activities) Uniondale New York

Sponsors (1)
Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Comparison of the rate of allogenic red blood cell transfusions between the Acute Normovolemic Hemodilution (ANH) and standard of care arm 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. up to 30 days from procedure
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