Clinical trial NCT00902343: Controlled Trial Comparing Nomogram-based Versus Standard Allocation of Acute Normovolemic Hemodilution (ANH) During Hepatic Resection
Official title: A Prospective Randomized Controlled Trial Comparing Nomogram-based Versus Standard Allocation of Acute Normovolemic Hemodilution (ANH) During Hepatic Resection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Liver Cancer
Keywords: Liver
Cancer
Primary
Metastatic
transfusions
08-158
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2009-05-15
Enrollment: 149
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to learn the best method of assigning patients to receive "acute normovolemic hemodilution" during liver surgery.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Adults (\>18 years).
* Preoperative hemoglobin concentration ≥ 11 mg/dl (males), ≥ 10 mg/dl (females) within 14 days of registration.
* Patients scheduled for hepatic resection for any indication, with or without other planned procedures

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 LV function within 30 days of operation.
* Patients with active or symptomatic cerebrovascular disease; patients with hemodynamically insignificant stenosis will not be deemed ineligible.
* A history of congestive heart failure.
* A history of uncontrolled hypertension.
* A history of restrictive or obstructive pulmonary disease.
* A history of renal dysfunction (Cr \> 1.8).
* Abnormal coagulation parameters (INR \> 1.5 in patients not on coumadin; an INR\>1.5 is acceptable in patients still on coumadin, provided drug is discontinued no less than 4 days prior to operation.)
* 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.
* Erythropoietin use
* Patients scheduled for ablation only
* Pregnant or lactating females

Primary outcomes:
measure: 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.
timeFrame: during surgery
Secondary outcomes:
measure: To assess the impact of nomogram-based allocation of ANH compared to standard allocation on the need for fresh frozen plasma (FFP) transfusions.
timeFrame: during surgery
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: William Jarnagin, MD
role: PRINCIPAL_INVESTIGATOR
References: