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A Pilot Study of Acute Normovolemic Hemodilution in Patients Undergoing Cytoreductive Surgery for Advanced Ovarian Cancer


N/A
18 Years
69 Years
Open (Enrolling)
Female
Epithelial Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Carcinoma

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Trial Information

A Pilot Study of Acute Normovolemic Hemodilution in Patients Undergoing Cytoreductive Surgery for Advanced 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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

the safety of performing acute normovolemic hemodilution (ANH)

Outcome Description:

Allogenic red blood cell transfusion rate will be measured as any transfusion during the operating procedure or during the hospitalization

Outcome Time Frame:

within 7 days

Safety Issue:

Yes

Principal Investigator

Dennis Chi, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

11-149

NCT ID:

NCT01442051

Start Date:

September 2011

Completion Date:

September 2014

Related Keywords:

  • Epithelial Ovarian Cancer
  • Fallopian Tube Cancer
  • Primary Peritoneal Carcinoma
  • Acute Normovolemic Hemodilution
  • Cytoreductive Surgery
  • laparotomy
  • 11-149
  • advanced primary epithelial ovarian cancer
  • Carcinoma
  • Ovarian Neoplasms
  • Fallopian Tube Neoplasms
  • Neoplasms, Glandular and Epithelial

Name

Location

Memorial Sloan Kettering Cancer Center New York, New York  10021