Using blood volume management during surgery for ovarian cancer patients
A Prospective Randomized Trial of Acute Normovolemic Hemodilution (ANH) in Patients Undergoing Cytoreductive Surgery for Ovarian Cancer
This study tests if a blood management technique called acute normovolemic hemodilution can help women with advanced ovarian cancer during surgery by reducing the need for blood transfusions and improving safety.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 86 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Memorial Sloan Kettering Cancer Center Academic / other |
| Drugs / interventions | Chemotherapy |
| Locations | 7 sites (Basking Ridge, New Jersey and 6 other locations) |
| Trial ID | NCT06290193 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of acute normovolemic hemodilution (ANH) in patients with advanced ovarian cancer undergoing cytoreductive surgery. Participants will be randomly assigned to receive either ANH or standard surgical management to assess its impact on reducing the need for allogenic blood transfusions during surgery. The study aims to determine if ANH can improve surgical outcomes and patient safety in this high-risk population. By comparing the two groups, researchers hope to gather data on the effectiveness of ANH in this context.
Who should consider this trial
Good fit: Ideal candidates are adults with advanced primary epithelial ovarian, fallopian tube, or peritoneal carcinoma scheduled for cytoreductive surgery.
Not a fit: Patients with a history of active coronary artery disease, cerebrovascular disease, congestive heart failure, or uncontrolled hypertension may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could reduce the need for blood transfusions during surgery, leading to better recovery outcomes for patients.
How similar studies have performed: Other studies have shown promising results with blood volume management techniques in surgical settings, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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 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)
Where this trial is running
Basking Ridge, New Jersey and 6 other locations
- Memoral Sloan Kettering at Basking Ridge (Limited Protocol Activities) — Basking Ridge, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Monmouth (Limited protocol activities) — Middletown, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Bergen (Limited protocol activities) — Montvale, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activities) — Commack, New York, United States (Recruiting)
- Memorial Sloan Kettering Westchester (Limited protocol activities) — Harrison, New York, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center (All protocol activities) — New York, New York, United States (Recruiting)
- Memorial Sloan Kettering Nassau (Limited Protocol Activities) — Uniondale, New York, United States (Recruiting)
Study contacts
- Principal investigator: Dennis Chi, MD — Memorial Sloan Kettering Cancer Center
- Study coordinator: Dennis Chi, MD
- Email: chid@mskcc.org
- Phone: 212-639-5016
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.