Hemodilution for Ovarian Cancer

Recruiting at 7 trial locations

Overseen By Ginger Gardner, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Coronary artery disease, Cerebrovascular disease, Congestive heart failure, Uncontrolled hypertension, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

86 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a treatment called acute normovolemic hemodilution (ANH) for individuals undergoing surgery for advanced ovarian cancer. Researchers aim to determine if ANH can reduce the need for blood transfusions during surgery. Participants will be randomly assigned to receive either ANH or the standard surgical procedure. This trial may suit adults with a high suspicion or diagnosis of advanced ovarian cancer who are scheduled for cytoreductive surgery. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important medical advancements.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that acute normovolemic hemodilution/ANH is safe for ovarian cancer surgery?

Research shows that acute normovolemic hemodilution (ANH) is generally well-tolerated by patients. Past studies found that ANH lowers the need for donor blood transfusions, which means patients might lose fewer red blood cells during surgery. This indicates its safety. Although detailed information on specific side effects is limited, the emphasis on reducing blood loss suggests that ANH is safe enough for further testing. For those considering joining this trial, ANH has been tested in surgeries with promising results for managing blood loss. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for ovarian cancer?

Researchers are excited about Acute Normovolemic Hemodilution (ANH) because it offers a new approach to managing blood loss during ovarian cancer surgeries. Unlike the standard of care, which typically involves transfusing donor blood, ANH works by removing and storing a patient's own blood before surgery, then returning it during or after the procedure. This method reduces the risk of transfusion-related complications and immunologic reactions. By using the patient's own blood, ANH could improve recovery times and outcomes, offering a safer alternative to traditional blood transfusions.

What evidence suggests that acute normovolemic hemodilution/ANH is effective for reducing the need for allogenic blood transfusion in ovarian cancer surgery?

Research has shown that acute normovolemic hemodilution (ANH), a technique participants in this trial may receive, can reduce the need for donor blood transfusions during surgery. ANH thins the blood, minimizing red blood cell loss if bleeding occurs. One study found that ANH lowered the risk of needing a blood transfusion, a common concern during major surgeries like those for ovarian cancer. Another study found that ANH reduced the overall loss of red blood cells, further supporting its potential benefits. These findings suggest that ANH might effectively manage blood loss during surgery for ovarian cancer patients. ^{1 3 5 6 7}

Who Is on the Research Team?

Dennis Chi, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for individuals with ovarian cancer or related conditions who are scheduled for primary cytoreductive surgery. Specific eligibility details aren't provided, but typically participants must meet certain health criteria to ensure safety and the ability to follow the study's procedures.

Inclusion Criteria

My hemoglobin level was at least 10 mg/dl within the last month.

My scans show advanced ovarian, fallopian tube, or peritoneal cancer.

BLOODS score ≥3 as calculated by surgeon

Exclusion Criteria

I have a history of lung disease that affects my breathing.

My kidney function is impaired (Creatinine >1.6 mg/dl).

Abnormal coagulation parameters (INR >1.5 not on coumadin, or platelet count <100,000 mcL)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo primary cytoreductive surgery with either acute normovolemic hemodilution (ANH) or standard surgical management

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after surgery, including the need for allogenic blood transfusions

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Acute Normovolemic Hemodilution/ANH

Trial Overview The trial is testing acute normovolemic hemodilution (ANH) during surgery against standard surgical management. Participants will be randomly assigned to one of these two approaches to see if ANH can reduce the need for blood transfusions during surgery.

How Is the Trial Designed?

Group I: Acute Normovolemic Hemodilution (ANH) Arm Experimental Treatment 1 Intervention

Group II: Standard Intraoperative Management Arm Active Control 1 Intervention

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Published Research Related to This Trial

In a study of 41 patients undergoing surgery for advanced ovarian cancer, acute normovolemic hemodilution (ANH) successfully reduced the rate of allogenic red blood cell transfusions to 34%, which is below the targeted reduction from a historical rate of 50%.

The use of ANH did not increase the rate of serious complications, with 20% experiencing ≥grade 3 complications and 7% having anastomotic leaks, indicating that ANH is a safe approach for managing blood loss during surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A prospective trial of acute normovolemic hemodilution in patients undergoing primary cytoreductive surgery for advanced ovarian cancer. Tanner, EJ., Filippova, OT., Gardner, GJ., et al.[2020]

A systematic review of 42 trials found that acute normovolemic hemodilution (ANH) does not significantly reduce the risk of allogeneic blood transfusions compared to usual care or other blood conservation methods, indicating limited efficacy.

While ANH resulted in less total bleeding compared to usual care, it also led to increased intraoperative bleeding, and the overall safety of the procedure remains uncertain, suggesting that its widespread use is not recommended.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preoperative acute normovolemic hemodilution: a meta-analysis. Segal, JB., Blasco-Colmenares, E., Norris, EJ., et al.[2022]

Acute normovolemic hemodilution (ANH) effectively reduces the need for allogenic red blood cell transfusions during primary debulking surgery for advanced ovarian cancer without negatively impacting oncologic outcomes, as shown in a study of 393 patients (33 in the ANH group and 360 in the standard group).

While ANH did not show a significant independent association with progression-free survival (PFS) or overall survival (OS), it maintained the ability to achieve complete gross resection, which is crucial for treatment success.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Survival outcomes of acute normovolemic hemodilution in patients undergoing primary debulking surgery for advanced ovarian cancer: A Memorial Sloan Kettering Cancer Center Team Ovary study. Boerner, T., Tanner, E., Filippova, O., et al.[2023]

Acute Normovolemic Hemodilution (ANH) significantly reduced the need for homologous blood transfusions in children undergoing posterior spinal fusion, with only 28% of the ANH group requiring transfusions compared to 79% in the control group.

The study found that ANH was safe, with no anemia-related complications reported, and it did not increase the risk of postoperative complications compared to the control group, suggesting it is an effective method for managing blood loss in pediatric surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute normovolemic hemodilution in children submitted to posterior spinal fusion. de Oliveira, GS., Tenório, SB., Cumino, DO., et al.[2014]

In a study involving 40 patients undergoing brain tumor surgery, acute normovolemic hemodilution (ANH) did not significantly affect cerebral oxygen balance compared to a control group receiving normal saline, indicating that ANH can be safely used without compromising cerebral oxygenation.

Both groups showed a decrease in cerebral metabolic rate for oxygen (eCMRO2) during surgery, but there were no significant differences in key oxygenation parameters between the ANH and control groups, suggesting that ANH is a viable alternative to allogenic blood transfusion in this surgical context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cerebral effect of acute normovolemic hemodilution during brain tumor resection. Daif, AA., Hassan, YM., Ghareeb, NA., et al.[2013]

In a study of 160 patients undergoing major gastrointestinal surgery, acute normovolaemic haemodilution (ANH) did not significantly reduce the rate of allogeneic blood transfusions compared to a control group, indicating limited efficacy in this context.

However, ANH was associated with a lower incidence of oliguria (47% vs 67%) in the immediate postoperative period, suggesting a potential benefit in kidney function despite increased anaesthetic time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective randomized controlled trial of acute normovolaemic haemodilution in major gastrointestinal surgery. Sanders, G., Mellor, N., Rickards, K., et al.[2022]

In a study of 114 patients undergoing partial hepatectomy, using a transfusion nomogram to select patients for acute normovolemic hemodilution (ANH) did not significantly improve overall management compared to traditional methods, with appropriate management rates of 80% versus 76%.

However, the nomogram approach led to a trend of reduced ANH use, particularly in patients with low estimated blood loss (≤ 400 mL), suggesting it may help avoid unnecessary procedures in low-risk cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Selecting patients for acute normovolemic hemodilution during hepatic resection: a prospective randomized evaluation of nomogram-based allocation. Frankel, TL., Fischer, M., Grant, F., et al.[2019]

Acute Normovolaemic Haemodilution (ANH) significantly reduced the need for homologous blood transfusions in patients undergoing maxillofacial surgery, showing better outcomes in hemoglobin (Hb%) and packed cell volume (PCV%) on postoperative days compared to those receiving homologous transfusions.

In a study of 30 healthy patients, ANH demonstrated greater efficacy in maintaining Hb% and PCV% levels post-surgery, indicating it may be a safer and more effective alternative to traditional blood transfusions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The clinical application of acute normovolaemic haemodilution in oral and maxillofacial surgeries. Goel, P., Bhola, N., Borle, RM., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8378264/

Survival Outcomes of Acute Normovolemic Hemodilution in ... It has been proven to reduce the need for ABT by diluting surgical blood loss, resulting in an overall decreased loss of red blood cells (RBC) ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1048891X24014555

A pre-operative scoring model to estimate the risk of blood ... Acute normovolemic hemodilution in this setting was investigated in a 2018 trial of 41 patients by Taner et al who reported a rate of 32% of allogenic red ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06290193

Study of Acute Normovolemic Hemodilution (ANH) in ... The researchers think acute normovolemic hemodilution/ANH may decrease the need for allogenic blood transfusion/ABT in people having primary cytoreductive ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30336947/

A prospective trial of acute normovolemic hemodilution in ... Cytoreductive outcomes were as follows: 0 mm, 30 (73%); 1-10 mm, 8 (20%); and >10 mm, 3 (7%) residual disease. Estimated blood loss was 1000 mL (range, 150-2700) ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT01442051

Acute Normovolemic Hemodilution in Patients Undergoing ... The purpose of this study is to help us learn how to lower the risk of a blood transfusion during surgery to remove ovarian cancer. Acute normovolemic ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33213899/

A Memorial Sloan Kettering Cancer Center Team Ovary study Objective: To describe oncologic outcomes after using acute normovolemic hemodilution (ANH) to reduce requirement for allogenic red blood cell ...

7. gynecologiconcology-online.net gynecologiconcology-online.net/article/S0090-8258(18)31285-X/abstract

A prospective trial of acute normovolemic hemodilution in ... Our objective was to determine the safety and efficacy of acute normovolemic hemodilution (ANH) to reduce the requirement for allogenic red blood cell (RBC) ...