Acute Normovolemic Hemodilution in Patients Undergoing Cytoreductive Surgery for Advanced Ovarian Cancer
| Status: | Recruiting |
|---|---|
| Conditions: | Ovarian Cancer, Cancer, Cancer, Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 69 |
| Updated: | 11/10/2018 |
| Start Date: | September 2011 |
| End Date: | September 2019 |
| Contact: | Dennis Chi, MD |
| Phone: | 212-639-5016 |
A Pilot Study of Acute Normovolemic Hemodilution in Patients Undergoing Cytoreductive Surgery for Advanced Ovarian Cancer
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.
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.
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.
We found this trial at
4
sites
500 Westchester Avenue
Harrison, New York 10604
Harrison, New York 10604
Phone: 212-639-5016
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1275 York Ave
New York, New York 10021
New York, New York 10021
(212) 639-2000
Principal Investigator: Dennis Chi, MD
Phone: 212-639-5016
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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