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.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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.
during surgery
Yes
William Jarnagin, MD
Principal Investigator
Memorial Sloan-Kettering Cancer Center
United States: Institutional Review Board
08-158
NCT00902343
May 2009
May 2013
Name | Location |
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Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |