Study of Acute Normovolemic Hemodilution (ANH) in People With Ovarian Cancer Who Are Having Cytor… (NCT06290193) | Clinical Trial Compass
RecruitingPhase 2
Study of Acute Normovolemic Hemodilution (ANH) in People With Ovarian Cancer Who Are Having Cytoreductive Surgery
United States86 participantsStarted 2024-02-23
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* 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 only diagnostic laparoscopy should not be included
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 45 days of surgery.
* 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 o…
What they're measuring
1
Comparison of the rate of allogenic red blood cell transfusions between the Acute Normovolemic Hemodilution (ANH) and standard of care arm