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

Not Applicable

Completed

• Conditions: Primary Peritoneal Carcinoma; Epithelial Ovarian Cancer; Fallopian Tube Cancer
• Interventions: Procedure: Acute Normovolemic Hemodilution

• Registration Number: NCT01442051
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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

Not available

Study Timeline

• Study Start: 2011-09-23
• Study First Submitted: 2011-09-23
• Study First Submitted QC: 2011-09-26
• Study First Posted: 2011-09-28
• Status Verified: 2018-07
• Primary Completion: 2019-07-01
• Study Completion: 2019-07-01
• Last Update Submitted: 2019-07-02
• Last Update Posted: 2019-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 52

Inclusion Criteria

• The study population will include women with a high preoperative suspicion of advanced primary epithelial ovarian, fallopian tube, or primary peritoneal carcinoma (Stage IIIC or IV) as determined by CT or MRI of abdomen and pelvis planning to undergo exploratory laparotomy and surgical cytoreduction with the operative goal of this procedure to achieve optimal cytoreduction to less than 1 cm of residual disease.
• Age ≥ 18 years and < 70 years.
• Preoperative hemoglobin concentration ≥ 10 mg/dL within 30 days of registration.
• Based on surgeon's assessment, patient is recommended to undergo cytoreductive surgery via laparotomy with the operative goal of this procedure to achieve optimal cytoreduction to less than 1 cm of residual disease.

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Exclusion Criteria

• Hemoglobin < 10 g/dL.
• Serum albumin < 3g/dL.
• GOG performance status > 2.
• Active coronary artery disease (defined as unstable angina or a positive cardiac stress test).
• Patients with a history of coronary artery disease may be included if they have had a normal cardiac stress test within 30 days of enrollment.
• History of cerebrovascular disease.
• Renal insufficiency with serum creatinine > 1.6.
• Uncontrolled hypertension.
• Restrictive or obstructive pulmonary disease.
• Congestive heart failure.
• Active infection.
• Pregnancy.
• Refusal to accept allogenic or autologous blood transfusion.
• Autologous blood transfusion within last 30 days or plan to donate autologous blood prior to surgery.
• Plan for exploratory laparoscopy prior to laparotomy for assessment of disease resectability.
• Surgeon has high suspicion (>50% chance) that cytoreductive surgery will be aborted due to inability to achieve optimal cytoreduction to < 1cm residual disease.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Acute Normovolemic Hemodilution	Acute Normovolemic Hemodilution	A pilot study will be performed. Intraoperative data including vital signs, procedures performed, and transfusions of allogenic blood will be collected prospectively. Postoperative outcomes, including transfusions of allogenic blood, perioperative complications, and 30-day mortality will be collected prospectively. These outcomes will be compared to historical controls to assess for the safety and efficacy of ANH in ovarian cancer cytoreductive surgery.

Primary Outcome Measures

Name	Time	Method
the safety of performing acute normovolemic hemodilution (ANH)	within 7 days	Allogenic red blood cell transfusion rate will be measured as any transfusion during the operating procedure or during the hospitalization

Secondary Outcome Measures

Name	Time	Method
length of hospitalization stay	2 years
postoperative complications	within 30 days of surgery	Careful assessment and recording of all intraoperative and postoperative complications within 30 days of surgery according to universal guidelines as established by the Gynecologic Oncology Group and affirmed by the Division of Gynecology at MSKCC.
operating time	Duration of surgical procedure	operative time will be compared to historical controls that received standard intraoperative management.
impact on transfusion rates	2 years	Allogenic red blood cell transfusion rate will be measured as any transfusion during the operating procedure or during the hospitalization. The charts of patients transfused outside of the guidelines will be flagged for auditing and will be reviewed by the PI. Such transfusions will be considered appropriate if a reasonable clinical justification is identified.

Trial Locations

Locations (4)

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

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

Memorial Sloan Kettering West Harrison; 🇺🇸 Harrison, New York, United States

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