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A Prospective Randomized Trial of Acute Normovolemic Hemodilution Compared to Standard Intraoperative Management in Patients Undergoing Major Hepatic Resection and Pancreaticoduodenectomy

Phase 3
18 Years
Not Enrolling
Pancreaticoduodenectomy, Hepatectomy

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Trial Information

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.

Inclusion Criteria:

- Adults (>18 years).

- Pre-operative hemoglobin concentration >= 11 mg/dl (males); >= 10 mg/dl (females)
within 14 days of registration.

- Patients scheduled for resection of 3 or more liver segments for any indication, with
or without other planned procedures or patients scheduled for pancreaticoduodenectomy

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 left ventricular (LV) function within 30 days of

- A history of cerebrovascular disease.

- A history of congestive heart failure.

- A history of uncontrolled hypertension.

- A history of restrictive or obstructive pulmonary disease.

- A history of renal dysfunction (creatinine [Cr] > 1.8).

- Abnormal coagulation parameters (International Normalized Ratio [INR] > 1.5 not on
Coumadin, or platelet count < 100,000).

- 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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

All patients will have their blood checked every 30 minutes during surgery

Safety Issue:


Principal Investigator

William R. Jarnagin, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

March 2004

Completion Date:

October 2011

Related Keywords:

  • Pancreaticoduodenectomy
  • Hepatectomy
  • Pancreaticoduodenectomy
  • Hepatectomy
  • Major Hepatic resection
  • Acute Normovolemic Hemodilution



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