Acute Normovolemic Hemodilution in Patients Undergoing Cytoreductive Surgery for Advanced Ovarian Cancer
Condition: Epithelial Ovarian Cancer; Fallopian Tube Cancer; Primary Peritoneal Carcinoma
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Fallopian Tube Neoplasms
Study type: Interventional

Summary: 
      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 hemodilution (ANH) is a technique
      performed in the operating room before the procedure begins that may reduce the risk of
      needing a transfusion during ovarian cancer surgery. During surgery, the patient's own blood
      is given back to them when needed, usually due to bleeding. If you don't need blood during
      surgery, your own blood will be given back at the end of the case.

      The idea behind ANH is that that by removing the blood and replacing it with other fluids,
      the remaining blood becomes diluted. This diluted blood is then lost during surgery, usually
      due to bleeding. The original non-diluted blood is then transfused back as needed. This may
      mean a lower chance of needing an additional blood transfusion.

      ANH has been studied at this hospital for other types of cancer. These studies suggest that
      ANH may help conserve blood. Although most studies suggest that ANH can be performed safely,
      one study showed that ANH could be associated with a higher rate of serious bowel
      complications than standard treatment. In this study, patients who underwent ANH had a higher
      rate of anastomotic leaks during bowel surgery. An anastomotic leak occurs when two ends of
      bowel that have been cut and sewn back together (the anastomosis), fall apart. The
      investigators don't know whether ANH will result in higher rates of anastomotic leaks in
      patients having ovarian cancer surgery. In fact, in another study evaluating ANH in patients
      having the kind of bowel resections that often occur in ovarian cancer surgery (the colon),
      no increased risk of anastomotic leaks was observed. For these reasons, researchers at MSKCC
      are conducting a study to find out if ANH can be used safely in patients undergoing surgery
      for ovarian cancer.
    


Intervention name(s): Acute Normovolemic Hemodilution
Intervention type(s): Procedure
Intervention description(s): A predetermined volume of whole blood will be removed from these patients based on an established protocol. Crystalloid and colloid will then be infused to replace intravascular volume based on this protocol. Patients will be closely monitored intraoperatively with serum arterial hemoglobin (HgB) levels drawn hourly. Patients will be transfused with autologous blood if HgB < 7.0 g/dL. If the volume of autologous blood has not been transfused within eight hours or by the completion of the procedure, the remainder will be transfused at that time. If the volume of autologous blood has been transfused and the patients require additional blood transfusions (HgB <7g.dL), allogenic blood will be transfused thereafter. These transfusion triggers are based on common intraoperative practice patterns. Patients may also be transfused intraoperatively at any time for a HgB ≥ 7.0 g/dL based on the judgment of the attending anesthesiologist or surgeon but the reason will be recorded.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acute Normovolemic Hemodilution; Cytoreductive Surgery; laparotomy; 11-149; advanced primary epithelial ovarian cancer