Clinical trial · Interventional
Study of Acute Normovolemic Hemodilution (ANH) in People With Ovarian Cancer Who Are Having Cytoreductive Surgery
A Prospective Randomized Trial of Acute Normovolemic Hemodilution (ANH) in Patients Undergoing Cytoreductive Surgery for Ovarian Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (10)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fallopian Tube Cancer | Malignant Fallopian Tube Neoplasm | ALIAS | 0.90 |
| Fallopian Tube Cancer Stage IIIC | Malignant Fallopian Tube Neoplasm | CURATED_BROADER | 0.78 |
| Fallopian Tube Cancer Stage IV | Malignant Fallopian Tube Neoplasm | CURATED_BROADER | 0.78 |
| Fallopian Tube Carcinoma | Fallopian Tube Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Ovarian Cancer Stage IIIC | Malignant Ovarian Neoplasm | CURATED_BROADER | 0.78 |
| Ovarian Cancer Stage IV | Malignant Ovarian Neoplasm | CURATED_BROADER | 0.78 |
| Ovarian Carcinoma | Ovarian Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Peritoneal Cancer | Malignant Peritoneal Neoplasm |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Acute Normovolemic Hemodilution/ANH | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Acute Normovolemic Hemodilution (ANH) Arm
- interventionNames
- Biological: Acute Normovolemic Hemodilution/ANH
- type
- NO_INTERVENTION
- label
- Standard Intraoperative Management Arm
Primary outcomes (1)
- measure
- Comparison of the rate of allogenic red blood cell transfusions between the Acute Normovolemic Hemodilution (ANH) and standard of care arm
- timeFrame
- up to 30 days from procedure
- description
- The primary objective of this study is to determine if ANH reduces the requirement for allogenic red cell transfusions in patients undergoing primary cytoreductive surgery for ovarian cancer.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 or autologous blood transfusion * Patients scheduled for cytoreductive surgery with planned Hyperthermic Intraperitoneal Chemotherapy (HIPEC)
References
Publications (0)
Data not yet available