NCT01442051

Acute Normovolemic Hemodilution in Patients Undergoing Cytoreductive Surgery for Advanced Ovarian Cancer

A Pilot Study of Acute Normovolemic Hemodilution in Patients Undergoing Cytoreductive Surgery for Advanced Ovarian Cancer

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: Female
• Age: 18 Years – 69 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Epithelial Ovarian Cancer
• Fallopian Tube Cancer
• Primary Peritoneal Carcinoma

Interventions

Type	Name	Description
PROCEDURE	Acute Normovolemic Hemodilution	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.

Timeline

• Start date: 2011-09-23
• Primary completion: 2019-07-01
• Completion: 2019-07-01
• First posted: 2011-09-28
• Last updated: 2019-07-05

Locations

4 sites across 1 country: United States