Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date July 2018
Source Memorial Sloan Kettering Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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.

Study Design


Intervention

Procedure:
Acute Normovolemic Hemodilution
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.

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT03393884 - Study of IMNN-001 (Also Known as GEN-1) With NACT for Treatment of Ovarian Cancer (OVATION 2) Phase 1/Phase 2
Completed NCT04546373 - Niraparib as Maintenance Therapy in Patients With Platinum Sensitive Recurrent Ovarian Cancer
Active, not recruiting NCT05456685 - IMGN853 With Carboplatin in Second-line Treatment of FRα Expressing, Platinum-sensitive Epithelial Ovarian Cancer Phase 2
Completed NCT02928549 - Factors Associated With the Use of a High Volume Cancer Center by Black Women With Ovarian Cancer: A Qualitative Study
Active, not recruiting NCT03648489 - Dual mTorc Inhibition in advanCed/Recurrent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer (of Clear Cell, Endometrioid and High Grade Serous Type, and Carcinosarcoma) Phase 2
Not yet recruiting NCT04983550 - Efficacy and Safety of SG001 Combined With PLD in Patients With Platinum-resistant Relapsed EOC Phase 2
Completed NCT02480374 - Study of Safety & Biological Activity of IP IMNN-001 (Also Known as GEN-1) With Neoadjuvant Chemo in Ovarian Cancer Phase 1
Completed NCT01899599 - PankoMab-GEX™ Versus Placebo as Maintenance Therapy in Advanced Ovarian Cancer Phase 2
Completed NCT03480750 - Trial of Trientine Plus Pegylated Liposomal Doxorubicin and Carboplatin in Epithelial Ovarian Cancer Phase 1/Phase 2
Completed NCT01610206 - A Randomized Study of Safety and Efficacy of Pazopanib and Gemcitabine in Persistent or Relapsed Ovarian Cancer Phase 2
Completed NCT01031381 - Study of RAD001 and Bevacizumab in Recurrent Ovarian, Peritoneal, and Fallopian Tube Cancer Phase 2
Completed NCT01219777 - Neoadjuvant Chemotherapy IV Carboplatin With Weekly Paclitaxel \Bevacizumab for Primary Ovarian Phase 1
Completed NCT00959582 - Positron Emission Tomography/Computed Tomography (PET/CT) in Relapsed Ovarian Cancer (MK-0000-143) Phase 1
Completed NCT00768144 - Sunitinib in Recurrent and Refractory Ovarian, Fallopian Tube and Peritoneal Carcinoma Phase 2
Suspended NCT00753480 - A Study of D4064A Administered to Patients With Recurrent or Persistent Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer Phase 1
Completed NCT00801320 - Primary Tumor Harvest for the Purpose of Possible Use in a Future Clinical Trial in Patients With Ovarian, Fallopian Tube or Primary Peritoneal Cancer N/A
Completed NCT00702299 - Alimta® Plus Cisplatin & Paclitaxel Given Intraperitonelly; First Line Tx Stage III Ovarian Cancer Phase 1
Recruiting NCT02349958 - Clinical Trial of Intraperitoneal Hyperthermic Chemotherapy Phase 2
Terminated NCT00418093 - Oxaliplatin, Gemcitabine and Bevacizumab in Women With Recurrent Mullerian Carcinoma Phase 2
Completed NCT00390234 - Ziv-aflibercept in Treating Patients With Locally Advanced, Unresectable, or Metastatic Gynecologic Soft Tissue Sarcoma Phase 2