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Trial Title:
Study of Acute Normovolemic Hemodilution (ANH) in People With Ovarian Cancer Who Are Having Primary Cytoreductive Surgery
NCT ID:
NCT06290193
Condition:
Ovarian Cancer
Fallopian Tube Carcinoma
Ovarian Carcinoma
Peritoneal Carcinoma
Ovarian Cancer Stage IIIC
Fallopian Tube Cancer Stage IIIC
Ovarian Cancer Stage IV
Fallopian Tube Cancer Stage IV
Fallopian Tube Cancer
Peritoneal Cancer
Conditions: Official terms:
Carcinoma
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Fallopian Tube Neoplasms
Conditions: Keywords:
ovarian cancer
ovarian carcinoma
ovarian cancer stage IIIC
ovarian cancer stage IV
fallopian tube cancer
fallopian tube carcinoma
fallopian tube cancer stage IIIC
fallopian tube cancer stage IV
peritoneal cancer
peritoneal carcinoma
Acute Normovolemic Hemodilution
Memorial Sloan Kettering Cancer Center
23-392
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
Acute Normovolemic Hemodilution/ANH
Description:
For participants randomized to ANH, the volume of blood to be removed will be calculated
using an established formula, based on preoperative hemoglobin, target hemoglobin after
hemodilution, and the patient's estimated blood volume.
Arm group label:
Acute Normovolemic Hemodilution (ANH) Arm
Summary:
Participants will be scheduled for primary cytoreductive surgery as part of their
standard care. Before surgery, participants will be assigned by chance to a study group.
Depending on which group they are in, they will receive either acute normovolemic
hemodilution/ANH during surgery or standard surgical management during surgery. The
researchers think acute normovolemic hemodilution/ANH may decrease the need for allogenic
blood transfusion/ABT in people having primary cytoreductive surgery.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Adults (≥18 years)
- BLOODS score ≥3 as calculated by surgeon
- 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
the abdomen/pelvis
- Planned for exploratory laparotomy and PCS
- Preoperative hemoglobin concentration ≥10 mg/dl within 30 days of registration
- Patients scheduled for PCS, with or without other planned procedures
Exclusion Criteria:
- A history of active coronary artery disease
o Patients with a history of coronary artery disease will be eligible if they have
had a cardiac stress study showing no reversible ischemia and normal LV function
within 30 days of operation.
- A history of cerebrovascular disease
- A history of congestive heart failure
- A history of uncontrolled hypertension
- A history of restrictive or obstructive pulmonary disease
- A history of renal dysfunction (Cr >1.6 mg/dl)
- Abnormal coagulation parameters (INR >1.5 not on coumadin, or platelet count
<100,000 mcL)
- Presence of active infection
- Evidence of hepatic metabolic disorder (bilirubin >2 mg/dl, ALT >75 U/L in the
absence of biliary tract obstruction)
- Preoperative autologous blood donation within last 30 days or plan to donate
autologous blood prior to surgery
- Refusal to accept allogenic or autologous blood transfusion
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Memoral Sloan Kettering at Basking Ridge (Limited Protocol Activities)
Address:
City:
Basking Ridge
Zip:
07920
Country:
United States
Status:
Recruiting
Contact:
Last name:
Dennis Chi, MD
Phone:
212-639-5016
Facility:
Name:
Memorial Sloan Kettering Monmouth (Limited protocol activities)
Address:
City:
Middletown
Zip:
07748
Country:
United States
Status:
Recruiting
Contact:
Last name:
Dennis Chi, MD
Phone:
212-639-5016
Facility:
Name:
Memorial Sloan Kettering Bergen (Limited protocol activities)
Address:
City:
Montvale
Zip:
07645
Country:
United States
Status:
Recruiting
Contact:
Last name:
Dennis Chi, MD
Phone:
212-639-5016
Facility:
Name:
Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activities)
Address:
City:
Commack
Zip:
11725
Country:
United States
Status:
Recruiting
Contact:
Last name:
Dennis Chi, MD
Phone:
212-639-5016
Facility:
Name:
Memorial Sloan Kettering Westchester (Limited protocol activities)
Address:
City:
Harrison
Zip:
10604
Country:
United States
Status:
Recruiting
Contact:
Last name:
Dennis Chi, MD
Phone:
212-639-5016
Facility:
Name:
Memorial Sloan Kettering Cancer Center (All protocol activities)
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Contact:
Last name:
Dennis Chi, MD
Phone:
212-639-5016
Facility:
Name:
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Address:
City:
Uniondale
Zip:
11553
Country:
United States
Status:
Recruiting
Contact:
Last name:
Dennis Chi, MD
Phone:
212-639-5016
Start date:
February 23, 2024
Completion date:
February 23, 2029
Lead sponsor:
Agency:
Memorial Sloan Kettering Cancer Center
Agency class:
Other
Source:
Memorial Sloan Kettering Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06290193
http://www.mskcc.org