Hepatectomy Clinical Trial
Official title:
A Prospective Randomized Trial of Acute Normovolemic Hemodilution Compared to Standard Intraoperative Management in Patients Undergoing Major Hepatic Resection and Pancreaticoduodenectomy
With a major liver or pancreas operation, there is a chance that one will require a
transfusion of blood products (either red blood cells or plasma). This may be necessary
during the operation or a few days after surgery. The surgeons at Memorial Sloan-Kettering
Cancer Center perform a very large number of liver or pancreas resections every year and
have pioneered techniques that minimize bleeding during the operation. Even so, liver or
pancreas operations such as the one that will be undergone carry a 50% chance of requiring a
transfusion. A technique that might lower the need for transfusions is called acute
normovolemic hemodilution (ANH). ANH was first introduced over twenty years ago and has been
used in many types of operations, including liver or pancreas resection. The studies done on
ANH at other hospitals suggest that it may help conserve blood. Researchers at Memorial
Sloan-Kettering Cancer Center are conducting a study to determine if ANH is better than the
'standard technique' that is currently used in all patients. The purpose of this study is to
find out which of the two techniques is better.
The purpose of the study is to see if ANH lowers the need for the transfusion of blood
products during and after liver or pancreas resection.
The second purpose of the study is to see how ANH changes the length of the operation, the
length of time one spends in the hospital, and the complication rate after surgery. The
researchers will also see if ANH requires any changes in the administration of anesthesia.
Despite improvements in peri-operative outcome, major hepatic resection and
pancreaticoduodenectomy remains associated with a high risk of major blood loss and
perioperative blood transfusion.The risks associated with allogeneic blood transfusions are
well-known, including immunosuppression, incompatible transfusion, and transmission of
infectious agents. Clearly, efforts to reduce the use of allogeneic blood products are
warranted in order to avoid potential transfusion-related complications, reduce hospital
cost and avoid periods of critical blood shortage.
ANH is an approach to blood conservation that involves removal of whole blood from a patient
immediately prior to an operation that is likely to be associated with significant blood
loss. Following blood removal, euvolemia is restored with crystalloid and/or colloid. The
harvested blood, which has a greater red cell mass than the blood lost intraoperatively, is
re-infused as needed during the procedure or at the completion of the operation. ANH is more
attractive than preoperative autologous blood donation for several reasons: it is
technically and logistically much simpler, it requires no special equipment and costs less
(no storage or administrative costs), it is associated with a lower chance of administration
error, it requires no obligate pre-operative delay and is not associated with a waste of
autologous units. In addition, because coagulation factors are preserved and later
re-infused, ANH may reduce the need for post-operative fresh frozen plasma (FFP).
Additionally, ANH may have an impact on low CVP anesthetic management during partial
hepatectomy, which is standard at MSKCC and at many other centers.
The present study will help elucidate the efficacy of ANH as a means of reducing the
allogeneic transfusion rate in patients undergoing major hepatic resection. If shown to be
effective in reducing the use of allogeneic blood products, ANH will not only impact the
current practice of hepatic resectional surgery but may also change current practice in
other surgical disciplines.
This will be a prospective randomized study. Eligible patients will be consented for the
trial prior to the operation.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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