NCT06290193RecruitingPhase 2
Study of Acute Normovolemic Hemodilution (ANH) in People With Ovarian Cancer Who Are Having Cytoreductive Surgery
A Prospective Randomized Trial of Acute Normovolemic Hemodilution (ANH) in Patients Undergoing Cytoreductive Surgery for Ovarian Cancer
Source: ClinicalTrials.gov · Last updated 1 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 86 (estimated)
- First submitted
- 26 Feb 2024
- Start date
- 23 Feb 2024
- Primary completion date
- 23 Feb 2029
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Diseases
- Ovarian cancer
- NCT number
- NCT06290193
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 86
- From 23 Feb 2024 to the primary completion date, 23 Feb 2029
- 7 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Preoperative autologous blood donation within last 30 days or plan to donate autologous blood prior to surgery
- Patients scheduled for cytoreductive surgery with planned Hyperthermic Intraperitoneal Chemotherapy (HIPEC)
Other illness
- 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
- Presence of active infection
Lab values
- 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)
- Evidence of hepatic metabolic disorder (bilirubin \>2 mg/dl, ALT \>75 U/L in the absence of biliary tract obstruction)
Other
- Refusal to accept allogenic or autologous blood transfusion
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Memoral Sloan Kettering at Basking Ridge (Limited Protocol Activities) Coordinator of this site? Confirm its status | Basking Ridge | United States | Recruiting |
| Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited Protocol Activities) Coordinator of this site? Confirm its status | Commack | United States | Recruiting |
| Memorial Sloan Kettering Westchester (Limited Protocol Activities) Coordinator of this site? Confirm its status | Harrison | United States | Recruiting |
| Memorial Sloan Kettering Monmouth (Limited Protocol Activities) Coordinator of this site? Confirm its status | Middletown | United States | Recruiting |
| Memorial Sloan Kettering Bergen (Limited Protocol Activities) Coordinator of this site? Confirm its status | Montvale | United States | Recruiting |
| Memorial Sloan Kettering Cancer Center (All Protocol Activities) Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Memorial Sloan Kettering Nassau (Limited Protocol Activities) Coordinator of this site? Confirm its status | Uniondale | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.