Fresh-Frozen Plasma Infusions to Reduce Risk of Bleeding Related to Invasive Procedures

Inclusion Criteria:

• Undergoing one of the following percutaneous abdominal or transjugular invasive procedures: liver biopsy; liver-biliary abscess drainage; biliary tree drainage; or radio-frequency ablation of hepatic tumor
• Platelet count greater than or equal to 70,000/microliter
• INR greater than or equal to 1.3 and less than or equal to 1.9 (must not be based on a sample drawn within 24 hours of any prior FFP treatment)
• A PTT less than or equal to 50 sec

Exclusion Criteria:

• Use of warfarin, heparin, low molecular weight heparin, or other anticoagulant therapy within 5 days of the planned procedure (exceptions: prophylactic heparin injections into central venous catheters for catheter maintenance, prophylactic heparin (standard or low-dose) for prevention of deep venous thrombosis, and/or aspirin)
• History of severe allergic reaction to plasma products
• Use of any of the following second-generation anti-platelet agents: abciximab, tirofiban, clopidogrel, or ticlopidine
• Currently receiving any dialysis
• History of clinically significant bleeding diathesis, including Hemophilia A or B, von Willebrand's Disease, or congenital Factor VII deficiency
• Known history of a coagulation-factor inhibitor within the month prior to the procedure (In the absence of a known history, testing is not required)
• Active major bleeding; bleeding from gastrointestinal, pulmonary, mouth/throat, genito-urinary tract, or central nervous system sites (excludes guaiac positive stool sample without gross blood or melena, minor epistaxis, minor gum bleeding, microscopic hematuria, superficial bruises, normal menses, or minor vaginal spotting)
• Pediatric patients requiring sedation in order to undergo a post-procedure ultrasound examination
• Already received FFP in the 24 hours before the planned invasive procedure