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

Trial Summary

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 data supports the effectiveness of the treatment Acute Normovolemic Hemodilution (ANH) for ovarian cancer?

Research shows that Acute Normovolemic Hemodilution (ANH) can reduce the need for blood transfusions during surgery for advanced ovarian cancer, which may help in managing blood supply and reducing potential transfusion-related complications. ^{1 2 3 4 5}

How is the treatment Acute Normovolemic Hemodilution (ANH) different from other treatments for ovarian cancer?

Acute Normovolemic Hemodilution (ANH) is unique because it involves removing some of the patient's blood before surgery and replacing it with fluids to maintain blood volume, which helps reduce the need for donor blood transfusions during surgery. This approach is different from typical treatments for ovarian cancer, which often focus on chemotherapy or surgery without this blood management strategy. ^{1 2 6 7 8}

What is the purpose of this trial?

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.

Research Team

Dennis Chi, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

A prospective trial of acute normovolemic hemodilution in patients undergoing primary cytoreductive surgery for advanced ovarian cancer. [2020]

2. United States 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. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Selecting patients for acute normovolemic hemodilution during hepatic resection: a prospective randomized evaluation of nomogram-based allocation. [2019]

4. India pubmed.ncbi.nlm.nih.gov

The clinical application of acute normovolaemic haemodilution in oral and maxillofacial surgeries. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Prospective randomized controlled trial of acute normovolaemic haemodilution in major gastrointestinal surgery. [2022]

6. Brazil pubmed.ncbi.nlm.nih.gov

Acute normovolemic hemodilution in children submitted to posterior spinal fusion. [2014]

7. United States pubmed.ncbi.nlm.nih.gov

Preoperative acute normovolemic hemodilution: a meta-analysis. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Cerebral effect of acute normovolemic hemodilution during brain tumor resection. [2013]