Back to resultsAcute Normovolemic Hemodilution in Patients Undergoing Cytoreductive Surgery for Advanced Ovarian Cancer
Primary Purpose
Epithelial Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Carcinoma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acute Normovolemic Hemodilution
Sponsored by
About this trial
This is an interventional treatment trial for Epithelial Ovarian Cancer focused on measuring Acute Normovolemic Hemodilution, Cytoreductive Surgery, laparotomy, 11-149, advanced primary epithelial 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.
Sites / Locations
- Memoral Sloan Kettering Cancer Center
- Memorial Sloan Kettering Cancer Center @ Suffolk
- Memorial Sloan Kettering West Harrison
- Memorial Sloan Kettering Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Acute Normovolemic Hemodilution
Arm Description
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
length of hospitalization stay
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.
operating time
operative time will be compared to historical controls that received standard intraoperative management.
Full Information
NCT ID
NCT01442051
First Posted
September 23, 2011
Last Updated
July 2, 2019
Sponsor
Memorial Sloan Kettering Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT01442051
Brief Title
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
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
September 23, 2011 (Actual)
Primary Completion Date
July 1, 2019 (Actual)
Study Completion Date
July 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epithelial Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Carcinoma
Keywords
Acute Normovolemic Hemodilution, Cytoreductive Surgery, laparotomy, 11-149, advanced primary epithelial ovarian cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Acute Normovolemic Hemodilution
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Acute Normovolemic Hemodilution
Intervention Description
A predetermined volume of whole blood will be removed from these patients based on an established protocol. Crystalloid and colloid will then be infused to replace intravascular volume based on this protocol. Patients will be closely monitored intraoperatively with serum arterial hemoglobin (HgB) levels drawn hourly. Patients will be transfused with autologous blood if HgB < 7.0 g/dL. If the volume of autologous blood has not been transfused within eight hours or by the completion of the procedure, the remainder will be transfused at that time. If the volume of autologous blood has been transfused and the patients require additional blood transfusions (HgB <7g.dL), allogenic blood will be transfused thereafter. These transfusion triggers are based on common intraoperative practice patterns. Patients may also be transfused intraoperatively at any time for a HgB ≥ 7.0 g/dL based on the judgment of the attending anesthesiologist or surgeon but the reason will be recorded.
Primary Outcome Measure Information:
Title
the safety of performing acute normovolemic hemodilution (ANH)
Description
Allogenic red blood cell transfusion rate will be measured as any transfusion during the operating procedure or during the hospitalization
Time Frame
within 7 days
Secondary Outcome Measure Information:
Title
impact on transfusion rates
Description
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.
Time Frame
2 years
Title
length of hospitalization stay
Time Frame
2 years
Title
postoperative complications
Description
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.
Time Frame
within 30 days of surgery
Title
operating time
Description
operative time will be compared to historical controls that received standard intraoperative management.
Time Frame
Duration of surgical procedure
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dennis Chi, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memoral Sloan Kettering Cancer Center
City
Basking Ridge
State/Province
New Jersey
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center @ Suffolk
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Facility Name
Memorial Sloan Kettering West Harrison
City
Harrison
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.mskcc.org/mskcc/html/44.cfm
Description
Memorial Sloan Kettering Cancer Center
Learn more about this trial
Acute Normovolemic Hemodilution in Patients Undergoing Cytoreductive Surgery for Advanced Ovarian Cancer
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