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Spots Global Cancer Trial Database for Acute Normovolemic Hemodilution in Patients Undergoing Cytoreductive Surgery for Advanced Ovarian Cancer

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Trial Identification

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

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

Study ID: NCT01442051

Study Description

Brief 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.

Detailed Description:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Memoral Sloan Kettering Cancer Center, Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Cancer Center @ Suffolk, Commack, New York, United States

Memorial Sloan Kettering West Harrison, Harrison, New York, United States

Memorial Sloan Kettering Cancer Center, New York, New York, United States

Contact Details

Name: Dennis Chi, MD

Affiliation: Memorial Sloan Kettering Cancer Center

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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