Ovarian CancerPhase 2NCT06290193
Study of Acute Normovolemic Hemodilution (ANH) in People With Ovarian Cancer Who Are Having Cytoreductive Surgery
A Phase 2 study testing Acute Normovolemic Hemodilution/ANH in people with Ovarian Cancer and Fallopian Tube Carcinoma, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ovarian Cancer, Fallopian Tube Carcinoma, Ovarian Carcinoma
- What is being tested?
- Acute Normovolemic Hemodilution/ANH
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 7 sitesUnited States
- Study dates
- 23 Feb 2024to 23 Feb 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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)
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
Memoral Sloan Kettering at Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920
Dennis Chi, MD, 212-639-5016
- Recruiting
Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activities)
Commack, New York, 11725
Dennis Chi, MD, 212-639-5016
- Recruiting
Memorial Sloan Kettering Westchester (Limited protocol activities)
Harrison, New York, 10604
Dennis Chi, MD, 212-639-5016
- Recruiting
Memorial Sloan Kettering Monmouth (Limited protocol activities)
Middletown, New Jersey, 07748
Dennis Chi, MD, 212-639-5016
- Recruiting
Memorial Sloan Kettering Bergen (Limited protocol activities)
Montvale, New Jersey, 07645
Dennis Chi, MD, 212-639-5016
- Recruiting
Memorial Sloan Kettering Cancer Center (All protocol activities)
New York, New York, 10065
Dennis Chi, MD, 212-639-5016
- Recruiting
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, 11553
Dennis Chi, MD, 212-639-5016
About this study
Official title: A Prospective Randomized Trial of Acute Normovolemic Hemodilution (ANH) in Patients Undergoing Cytoreductive Surgery for Ovarian Cancer
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.
- Conditions
- Ovarian Cancer, Fallopian Tube Carcinoma, Ovarian Carcinoma, Peritoneal Carcinoma, Ovarian Cancer Stage IIIC, Fallopian Tube Cancer Stage IIIC
- Being tested
- Acute Normovolemic Hemodilution/ANH
- Keywords
- ovarian cancer, ovarian carcinoma, ovarian cancer stage IIIC, ovarian cancer stage IV, fallopian tube cancer, fallopian tube carcinoma, fallopian tube cancer stage IIIC, fallopian tube cancer stage IV, peritoneal cancer, peritoneal carcinoma, Acute Normovolemic Hemodilution, Memorial Sloan Kettering Cancer Center, 23-392
- Medical subject headings
- Ovarian Neoplasms, Fallopian Tube Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acute Normovolemic Hemodilution/ANHBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| Acute Normovolemic Hemodilution (ANH) Arm | Experimental | Not described Receives: Biological: Acute Normovolemic Hemodilution/ANH |
| Standard Intraoperative Management Arm | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 30 days from procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start23 Feb 2024
- Primary completion23 Feb 2029 (estimated)
- Study completion23 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dennis Chi, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06290193
- Sponsor's protocol ID
- 23-392
- Status last verified
- Mar 2026
- First submitted
- 26 Feb 2024
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Trial of Acute Normovolemic Hemodilution (ANH) in Patients Undergoing Cytoreductive Surgery for Ovarian Cancer
- ClinicalTrials.gov ID
- NCT06290193
- Acronym / sponsor ID
- 23-392
- Conditions
- Ovarian Cancer, Fallopian Tube Carcinoma, Ovarian Carcinoma, Peritoneal Carcinoma, Ovarian Cancer Stage IIIC, Fallopian Tube Cancer Stage IIIC
- Keywords
- ovarian cancer, ovarian carcinoma, ovarian cancer stage IIIC, ovarian cancer stage IV, fallopian tube cancer, fallopian tube carcinoma, fallopian tube cancer stage IIIC, fallopian tube cancer stage IV
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 23 Feb 2024 (actual)
- Primary completion
- 23 Feb 2029 (estimated)
- Study completion
- 23 Feb 2029 (estimated)
- First posted
- 4 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acute Normovolemic Hemodilution (ANH) Arm | Experimental | Biological: Acute Normovolemic Hemodilution/ANH |
| Standard Intraoperative Management Arm | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acute Normovolemic Hemodilution/ANHFor 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. | Biological | Acute Normovolemic Hemodilution (ANH) Arm |
Primary outcome
Comparison of the rate of allogenic red blood cell transfusions between the Acute Normovolemic Hemodilution (ANH) and standard of care arm
Time frame: up to 30 days from procedure
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dennis Chi, MD principal investigator
Memorial Sloan Kettering Cancer Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Acute Normovolemic Hemodilution/ANH in people with Ovarian Cancer and Fallopian Tube Carcinoma, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dennis Chi, MD (212-639-5016, chid@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the rate of allogenic red blood cell transfusions between the Acute Normovolemic Hemodilution (ANH) and standard of care arm (time frame: up to 30 days from procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.