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New treatment option for Ovarian Cancer
Official title Study of Acute Normovolemic Hemodilution (ANH) in People With Ovarian Cancer Who Are Having Cytoreductive Surgery
ClinicalTrials.gov ID: NCT06290193
What this study is testing
What is Acute Normovolemic Hemodilution/ANH?
Acute Normovolemic Hemodilution/ANH is an investigational medicine, being studied as a potential treatment for ovarian cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Planned for exploratory laparotomy and primary or interval cytoreductive surgery
- Preoperative hemoglobin concentration ≥10 mg/dl within 45 days of surgery
You likely can't join if
- 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...
- 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)
See the full eligibility 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
- 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...
- 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
- Patients scheduled for cytoreductive surgery with planned Hyperthermic Intraperitoneal Chemotherapy (HIPEC)
The study team makes the final eligibility decision.
Where it's taking place
- Basking Ridge, New Jersey, United States
- Middletown, New Jersey, United States
- Montvale, New Jersey, United States
- Commack, New York, United States
- Harrison, New York, United States
- New York, New York, United States
- Uniondale, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Basking Ridge, New Jersey, United States; Middletown, New Jersey, United States; Montvale, New Jersey, United States; Commack, New York, United States; Harrison, New York, United States; New York, New York, United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.