Clinical trial · Interventional
Controlled Trial Comparing Nomogram-based Versus Standard Allocation of Acute Normovolemic Hemodilution (ANH) During Hepatic Resection
A Prospective Randomized Controlled Trial Comparing Nomogram-based Versus Standard Allocation of Acute Normovolemic Hemodilution (ANH) During Hepatic Resection
NCT00902343CI-TRIAL-00018829completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- 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)
The purpose of this study is to learn the best method of assigning patients to receive "acute normovolemic hemodilution" during liver surgery.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Liver Cancer | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| nomogram-based selection for acute normovolemic hemodilution | Procedure | — | UNRESOLVED |
| standard selection for ANH based on a planned resection of 3 or more segments | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- description
- nomogram-based selection for acute normovolemic hemodilution
- interventionNames
- Procedure: nomogram-based selection for acute normovolemic hemodilution
- type
- ACTIVE_COMPARATOR
- label
- 2
- description
- standard selection for ANH based on a planned resection of 3 or more segments.
- interventionNames
- Procedure: standard selection for ANH based on a planned resection of 3 or more segments
Primary outcomes (1)
- measure
- To determine if nomogram-based allocation of ANH is superior to allocation using extent of resection alone (planned resection of 3 or more liver segments) in patients undergoing partial hepatectomy.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adults (\>18 years). * Preoperative hemoglobin concentration ≥ 11 mg/dl (males), ≥ 10 mg/dl (females) within 14 days of registration. * Patients scheduled for hepatic resection for any indication, with or without other planned procedures Exclusion Criteria: * A history of active coronary artery disease. * 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 30 days of operation. * Patients with active or symptomatic cerebrovascular disease; patients with hemodynamically insignificant stenosis will not be deemed ineligible. * 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 \> 1.8). * Abnormal coagulation parameters (INR \> 1.5 in patients not on coumadin; an INR\>1.5 is acceptable in patients still on coumadin, provided drug is discontinued no less than 4 days prior to operation.) * Presence of active infection. * Evidence of hepatic metabolic disorder (bilirubin \> 2 mg/dl, ALT \> 75 U/L in the absence of biliary tract obstruction). * Pre-operative autologous blood donation. * Erythropoietin use * Patients scheduled for ablation only * Pregnant or lactating females
References
Publications (0)
Data not yet available
No reference posted for this study.