Study of Acute Normovolemic Hemodilution (ANH) in People With Ovarian Cancer Who Are Having Cytoreductive Surgery

Part of paid clinical trials in Basking Ridge, New Jersey.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT06290193
Phase
PHASE2
Status
Recruiting
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Conditions

  • Fallopian Tube Cancer
  • Fallopian Tube Cancer Stage IIIC
  • Fallopian Tube Cancer Stage IV
  • Fallopian Tube Carcinoma
  • Ovarian Cancer
  • Ovarian Cancer Stage IIIC
  • Ovarian Cancer Stage IV
  • Ovarian Carcinoma
  • Peritoneal Cancer
  • Peritoneal Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Acute Normovolemic Hemodilution/ANH — BIOLOGICAL
    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.

Study Details

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.

Key Dates

Start date
Feb 23, 2024
Status verified
Mar 2026
Primary completion
Feb 23, 2029
Completion
Feb 23, 2029

Study Design

Enrollment
86 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Acute Normovolemic Hemodilution (ANH) Arm
  • No Intervention: Standard Intraoperative Management Arm

Primary Outcome Measure

Comparison of the rate of allogenic red blood cell transfusions between the Acute Normovolemic Hemodilution (ANH) and standard of care arm [ Time Frame: up to 30 days from procedure ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Memoral Sloan Kettering at Basking Ridge (Limited Protocol Activities)Basking RidgeNew Jersey07920
Dennis Chi, MD
212-639-5016
Memorial Sloan Kettering Monmouth (Limited protocol activities)MiddletownNew Jersey07748
Dennis Chi, MD
212-639-5016
Memorial Sloan Kettering Bergen (Limited protocol activities)MontvaleNew Jersey07645
Dennis Chi, MD
212-639-5016
Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activities)CommackNew York11725
Dennis Chi, MD
212-639-5016
Memorial Sloan Kettering Westchester (Limited protocol activities)HarrisonNew York10604
Dennis Chi, MD
212-639-5016
Memorial Sloan Kettering Cancer Center (All protocol activities)New YorkNew York10065
Dennis Chi, MD
212-639-5016
Memorial Sloan Kettering Nassau (Limited Protocol Activities)UniondaleNew York11553
Dennis Chi, MD
212-639-5016

Find similar trials in Basking Ridge, NJ

By condition
Ovarian cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
Memoral Sloan Kettering at Basking Ridge (Limited Protocol Activities)· Basking Ridge, NJMemorial Sloan Kettering Monmouth (Limited protocol activities)· Middletown, NJMemorial Sloan Kettering Bergen (Limited protocol activities)· Montvale, NJMemorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activities)· Commack, NYMemorial Sloan Kettering Westchester (Limited protocol activities)· Harrison, NYMemorial Sloan Kettering Cancer Center (All protocol activities)· New York, NY

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