A Prospective Randomized Trial of Acute Normovolemic Hemodilution (ANH) in Patients Undergoing Cytoreductive Surgery for Ovarian Cancer

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Adults (≥18 years)

• BLOODS score ≥2 as calculated by surgeon

• High preoperative suspicion (or diagnosis) 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 primary or interval cytoreductive surgery

• Preoperative hemoglobin concentration ≥10 mg/dl within 45 days of surgery

• Patients scheduled for cytoreductive surgery, with or without other planned procedures o Note: Patients scheduled for diagnostic laparoscopy should not be included

Locations
United States
New Jersey
Memoral Sloan Kettering at Basking Ridge (Limited Protocol Activities)
RECRUITING
Basking Ridge
Memorial Sloan Kettering Monmouth (Limited protocol activities)
RECRUITING
Middletown
Memorial Sloan Kettering Bergen (Limited protocol activities)
RECRUITING
Montvale
New York
Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activities)
RECRUITING
Commack
Memorial Sloan Kettering Cancer Center (All protocol activities)
RECRUITING
New York
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
RECRUITING
Uniondale
Memorial Sloan Kettering Westchester (Limited protocol activities)
RECRUITING
West Harrison
Contact Information
Primary
Dennis Chi, MD
chid@mskcc.org
212-639-5016
Backup
Ginger Gardner, MD
gardnerg@mskcc.org
212-639-2375
Time Frame
Start Date: 2024-02-23
Estimated Completion Date: 2029-02-23
Participants
Target number of participants: 86
Treatments
Experimental: Acute Normovolemic Hemodilution (ANH) Arm
No_intervention: Standard Intraoperative Management Arm
Related Therapeutic Areas
Sponsors
Leads: Memorial Sloan Kettering Cancer Center

This content was sourced from clinicaltrials.gov