Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2025-12-25 @ 1:06 AM
NCT ID:
NCT06290193
Eligibility Criteria:
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 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 or autologous blood transfusion
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06290193
Study Brief:
Protocol Section:
NCT06290193