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.
Status | Completed |
Enrollment | 372 |
Est. completion date | October 2011 |
Est. primary completion date | October 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Memorial Sloan-Kettering Cancer Center | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Memorial Sloan Kettering Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Yes | |
Secondary | To determine if ANH reduces the requirement for allogeneic FFP 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 | Yes | |
Secondary | To determine the impact of ANH on post-operative complications, length of hospital stay and operating time compared to standard intraoperative management | Two weeks | Yes | |
Secondary | To assess the impact of ANH on low central venous pressure (CVP) anesthetic management during partial hepatectomy | Continuous monitoring during surgery | Yes |
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