Controlled Trial Comparing Nomogram-based Versus Standard Allocation of Acute Normovolemic Hemodilution (ANH) During Hepatic Resection
Completed · Phase 3
Conditions studied: Liver Cancer
In brief
The purpose of this study is to learn the best method of assigning patients to receive "acute normovolemic hemodilution" during liver surgery.
Key facts
- Study ID
- NCT00902343
- Run by
- Memorial Sloan Kettering Cancer Center
- People needed
- 149
- Starts
- 2009-05-01
- Expected to finish
- 2015-04-01
- Last updated by the study team
- 2015-08-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Memorial Sloan Kettering Cancer Center — New York, New York, United States
Full record on ClinicalTrials.gov
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