Clinical trial NCT01442051: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epithelial Ovarian Cancer
Fallopian Tube Cancer
Primary Peritoneal Carcinoma
Keywords: Acute Normovolemic Hemodilution
Cytoreductive Surgery
laparotomy
11-149
advanced primary epithelial ovarian cancer
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2011-09-28
Enrollment: 52
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

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.

Primary outcomes:
measure: the safety of performing acute normovolemic hemodilution (ANH)
timeFrame: within 7 days
Secondary outcomes:
measure: impact on transfusion rates
timeFrame: 2 years
measure: length of hospitalization stay
timeFrame: 2 years
measure: postoperative complications
timeFrame: within 30 days of surgery
measure: operating time
timeFrame: Duration of surgical procedure
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memoral Sloan Kettering Cancer Center
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Cancer Center @ Suffolk
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering West Harrison
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Dennis Chi, MD
role: PRINCIPAL_INVESTIGATOR
References: