Using blood volume management during surgery for ovarian cancer patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.