Acute Normovolemic Hemodilution Versus Standard Intraoperative Management in Patients Having Hepatic Resection and Pancreaticoduodenectomy

Completed · Phase 3

Conditions studied: Pancreaticoduodenectomy, Hepatectomy

In brief

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.

Key facts

Study ID

NCT00200148

Run by

Memorial Sloan Kettering Cancer Center

People needed

372

Starts

2004-03-01

Expected to finish

2011-10-01

Last updated by the study team

2015-03-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 operation.
• 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.

Where it is running

• Memorial Sloan-Kettering Cancer Center — New York, New York, United States

Full record on ClinicalTrials.gov

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