Status:
COMPLETED
Acute Normovolemic Hemodilution Versus Standard Intraoperative Management in Patients Having Hepatic Resection and Pancreaticoduodenectomy
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Conditions:
Pancreaticoduodenectomy
Hepatectomy
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 fe...
Detailed Description
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 risk...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
372 Patients enrolled
Trial Details
Trial ID
NCT00200148
Start Date
March 1 2004
End Date
October 1 2011
Last Update
March 6 2015
Active Locations (1)
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1
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021