Hemodilution for Ovarian Cancer
Recruiting in Palo Alto (17 mi)
+7 other locations
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Memorial Sloan Kettering Cancer Center
No Placebo Group
Prior Safety Data
Approved in 1 jurisdiction
Trial Summary
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.
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.
13478What 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.
25678Will 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.
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.Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Acute Normovolemic Hemodilution (ANH) ArmExperimental Treatment1 Intervention
Group II: Standard Intraoperative Management ArmActive Control1 Intervention
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Memorial Sloan Kettering Nassau (Limited Protocol Activities)Uniondale, NY
Memorial Sloan Kettering Westchester (Limited protocol activities)West Harrison, NY
Memoral Sloan Kettering at Basking Ridge (Limited Protocol Activities)Basking Ridge, NJ
Memorial Sloan Kettering Bergen (Limited protocol activities)Montvale, NJ
More Trial Locations
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Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
References
Preoperative acute normovolemic hemodilution: a meta-analysis. [2022]Acute normovolemic hemodilution (ANH) involves withdrawal of whole blood with concurrent infusion of fluids to maintain normovolemia. The aim of this study was to quantify the efficacy and safety of preoperative ANH with a systematic review and meta-analysis.
Prospective randomized controlled trial of acute normovolaemic haemodilution in major gastrointestinal surgery. [2022]The efficacy of acute normovolaemic haemodilution (ANH) remains uncertain because of a lack of well-designed prospective randomized controlled trials. The aim of this study was to assess the effects of ANH on allogeneic transfusion, postoperative complications, and duration of stay.
Acute normovolemic hemodilution in children submitted to posterior spinal fusion. [2014]Acute Normovolemic Hemodilution (ANH) is a simple and low-cost autologous transfusion method. This study aimed at evaluating whether ANH is able to decrease homologous transfusions in children undergoing posterior spinal fusion and at verifying hemodilution-induced complications in those patients.
Cerebral effect of acute normovolemic hemodilution during brain tumor resection. [2013]Acute normovolemic hemodilution (ANH) is used in major surgery expected to be accompanied by excessive blood loss. Reducing the hemoglobin content may disturb cerebral oxygen balance. The aim of this study was to assess the effect of ANH on cerebral oxygen balance in patients subjected to brain tumor resection.
The clinical application of acute normovolaemic haemodilution in oral and maxillofacial surgeries. [2021]The aim of the study is to assess the efficacy of Acute Normovolaemic Haemodilution (ANH) in reducing the perioperative homologous transfusion, to compare the results of acute normovolaemic haemodilution and homologous blood transfusion in terms of Hb%, PCV%, and to assess the cost effectiveness of ANH with homologous transfusion.
Selecting patients for acute normovolemic hemodilution during hepatic resection: a prospective randomized evaluation of nomogram-based allocation. [2019]Acute normovolemic hemodilution (ANH) decreases transfusion rates but adds to the complexity of anesthetic management during hepatectomy. A randomized controlled trial was conducted to determine if selecting patients for ANH using a transfusion nomogram improves management and resource use compared with selection using extent of resection.
A prospective trial of acute normovolemic hemodilution in patients undergoing primary cytoreductive surgery for advanced ovarian cancer. [2020]Our objective was to determine the safety and efficacy of acute normovolemic hemodilution (ANH) to reduce the requirement for allogenic red blood cell (RBC) transfusions in patients undergoing primary cytoreduction for advanced ovarian cancer.
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]To describe oncologic outcomes after using acute normovolemic hemodilution (ANH) to reduce requirement for allogenic red blood cell transfusions (ABT) in patients undergoing primary debulking surgery (PDS) for advanced ovarian cancer.