A Prospective Randomized Trial of Acute Normovolemic Hemodilution Compared to Standard Intraoperative Management in Patients Undergoing Major Hepatic Resection and Pancreaticoduodenectomy
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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
To determine if ANH reduces the requirement for allogeneic red cell transfusions in patients undergoing major hepatic resection or pancreaticoduodenectomy compared to standard intraoperative management
All patients will have their blood checked every 30 minutes during surgery
William R. Jarnagin, M.D.
Memorial Sloan-Kettering Cancer Center
United States: Institutional Review Board
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