Status:
COMPLETED
Controlled Trial Comparing Nomogram-based Versus Standard Allocation of Acute Normovolemic Hemodilution (ANH) During Hepatic Resection
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Conditions:
Liver Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to learn the best method of assigning patients to receive "acute normovolemic hemodilution" during liver surgery.
Detailed Description
For many patients, the best treatment for tumors in the liver is surgery, which is called liver resection. With major liver surgery, there is a chance that you will require a transfusion of blood prod...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
149 Patients enrolled
Trial Details
Trial ID
NCT00902343
Start Date
May 1 2009
End Date
April 1 2015
Last Update
August 13 2015
Active Locations (1)
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1
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065