Fallopian Tube Cancer Clinical Trial
Official title:
A Pilot Study of Acute Normovolemic Hemodilution in Patients Undergoing Cytoreductive Surgery for Advanced Ovarian Cancer
NCT number | NCT01442051 |
Other study ID # | 11-149 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | September 23, 2011 |
Est. completion date | July 1, 2019 |
Verified date | July 2018 |
Source | Memorial Sloan Kettering Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 52 |
Est. completion date | July 1, 2019 |
Est. primary completion date | July 1, 2019 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 69 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | 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 |
Lead Sponsor | Collaborator |
---|---|
Memorial Sloan Kettering Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | the safety of performing acute normovolemic hemodilution (ANH) | Allogenic red blood cell transfusion rate will be measured as any transfusion during the operating procedure or during the hospitalization | within 7 days | |
Secondary | impact on transfusion rates | 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. | 2 years | |
Secondary | length of hospitalization stay | 2 years | ||
Secondary | postoperative complications | 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. | within 30 days of surgery | |
Secondary | operating time | operative time will be compared to historical controls that received standard intraoperative management. | Duration of surgical procedure |
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