Controlled Trial Comparing Nomogram-based Versus Standard Allocation of Acute Normovolemic Hemodilution (ANH) During Hepatic Resection
|Liver Cancer||Procedure: nomogram-based selection for acute normovolemic hemodilution Procedure: standard selection for ANH based on a planned resection of 3 or more segments||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Prospective Randomized Controlled Trial Comparing Nomogram-based Versus Standard Allocation of Acute Normovolemic Hemodilution (ANH) During Hepatic Resection|
- 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. [ Time Frame: during surgery ]
- To assess the impact of nomogram-based allocation of ANH compared to standard allocation on the need for fresh frozen plasma (FFP) transfusions. [ Time Frame: during surgery ]
|Study Start Date:||May 2009|
|Study Completion Date:||April 2015|
|Primary Completion Date:||April 2015 (Final data collection date for primary outcome measure)|
nomogram-based selection for acute normovolemic hemodilution
Procedure: nomogram-based selection for acute normovolemic hemodilution
Will use the nomogram to determine whether or not the patient needs ANH during surgery. The nomogram assigns a point value to certain pre-op factors to determine whether or not the patient will need an ANH. Preoperative factors that will be used are platelet count, planned amount of liver to be removed, hemoglobin level, if the surgeon needs to operate on any organ outside of the liver to remove the tumor, and the patients health overall.
Active Comparator: 2
standard selection for ANH based on a planned resection of 3 or more segments.
Procedure: standard selection for ANH based on a planned resection of 3 or more segments
Will use the planned amount of liver to be removed to determine whether or not the patient needs an ANH during surgery.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00902343
|United States, New York|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||William Jarnagin, MD||Memorial Sloan Kettering Cancer Center|