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A Prospective Randomized Controlled Trial Comparing Nomogram-based Versus Standard Allocation of Acute Normovolemic Hemodilution (ANH) During Hepatic Resection

Phase 3
18 Years
Open (Enrolling)
Liver Cancer

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Trial Information

A Prospective Randomized Controlled Trial Comparing Nomogram-based Versus Standard Allocation of Acute Normovolemic Hemodilution (ANH) During Hepatic Resection

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 products (either red blood cells or plasma) either during, or a few
days after surgery. The surgeons at Memorial Sloan-Kettering Cancer Center (MSKCC) perform a
very large number of liver resections every year, and have pioneered techniques that
minimize bleeding during the operation. Even so, liver operations such as the one you will
undergo have a 30% chance of requiring a transfusion. One technique that has been shown to
lower the need for transfusions is called "acute normovolemic hemodilution (ANH)". ANH was
first introduced over 20 years ago, and has been used in many types of operations, including
liver resection. The studies done on ANH here at MSKCC and at other hospitals suggest that
it may help conserve blood and lower the risk of you needing a blood transfusion. In fact,
a recent study completed here showed that patients who received ANH while undergoing a major
liver resection were half as likely to require a blood transfusion.

Researchers at MSKCC are conducting a study to determine the best way to assign patients to
receive ANH. Currently, patients are assigned to undergo ANH based on the amount of liver
that is expected to be removed (also called 'extent of resection'). We are looking at
whether assigning patients to receive ANH based on a nomogram more appropriately selects
patients who would benefit from undergoing ANH. A nomogram is a predictive mathematical
tool that uses a point system to evaluate each patient's anticipated blood transfusion needs
based on the data from many previous patients with the same condition(s). Using this method,
your risk of requiring a blood transfusion will be calculated, and depending on the
predicted risk of transfusion, you may or may not be selected to undergo ANH. All patients
will undergo randomization (a computer-generated decision, as in the flip of a coin): half
will be assigned to the arm using the nomogram-based selection for ANH, and half will be
assigned based on the planned operative procedure.

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome 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.

Outcome Time Frame:

during surgery

Safety Issue:


Principal Investigator

William Jarnagin, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

May 2009

Completion Date:

May 2013

Related Keywords:

  • Liver Cancer
  • Liver
  • Cancer
  • Primary
  • Metastatic
  • transfusions
  • 08-158
  • Liver Neoplasms



Memorial Sloan-Kettering Cancer Center New York, New York  10021