Status:
COMPLETED
Acute Normovolemic Hemodilution in Patients Undergoing Cytoreductive Surgery for Advanced Ovarian Cancer
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Conditions:
Epithelial Ovarian Cancer
Fallopian Tube Cancer
Eligibility:
FEMALE
18-69 years
Phase:
NA
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 th...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 23 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2019
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT01442051
Start Date
September 23 2011
End Date
July 1 2019
Last Update
July 5 2019
Active Locations (4)
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1
Memoral Sloan Kettering Cancer Center
Basking Ridge, New Jersey, United States
2
Memorial Sloan Kettering Cancer Center @ Suffolk
Commack, New York, United States, 11725
3
Memorial Sloan Kettering West Harrison
Harrison, New York, United States, 10604
4
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065