Acute Normovolemic Hemodilution in Patients Undergoing Cytoreductive Surgery for Advanced Ovarian Cancer

NCT01442051 | Completed

• 1 other identifier: 11-149
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 4

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.

Conditions

Epithelial Ovarian Cancer; Fallopian Tube Cancer; Primary Peritoneal Carcinoma

Keywords

Acute Normovolemic Hemodilution; Cytoreductive Surgery; laparotomy; 11-149; advanced primary epithelial ovarian cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• impact on transfusion rates

  2 years

• length of hospitalization stay

  2 years

• postoperative complications

  within 30 days of surgery

• operating time

  Duration of surgical procedure

Study Arms (1)

Acute Normovolemic Hemodilution

EXPERIMENTAL

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.

Procedure: Acute Normovolemic Hemodilution

Interventions

Acute Normovolemic Hemodilution PROCEDURE

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.

Acute Normovolemic Hemodilution

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (4)

Memoral Sloan Kettering Cancer Center

Basking Ridge, New Jersey, United States

Location

Memorial Sloan Kettering Cancer Center @ Suffolk

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering West Harrison

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Carcinoma, Ovarian Epithelial; Fallopian Tube Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Ovarian Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Fallopian Tube Diseases

Study Officials

• Dennis Chi, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2011
• First Posted: September 28, 2011
• Study Start: September 23, 2011
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: July 5, 2019

Record last verified: 2018-07

Locations

US (4)