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

Withdrawn before enrolling · Phase 3

Conditions studied: Blood Coagulation Disorders

In brief

This study will compare patients with mild to moderate prolongation of the INR test who receive FFP infusions prior to invasive hepatobiliary procedures for bleeding complications to patients who do not receive FFP infusions. Bleeding complications will be defined as meeting one or more of the following: 1. Intrahepatic hematoma greater than 1 ml/kg of patient weight as seen on post-procedure ultrasound examination performed between 4 to 30 hours after the procedure. 2. Greater than 1.6g/dL hemoglobin decline measured within 4 to 30 hours post-procedure compared with the pre-procedure value, in the absence of another identified bleeding source to account for the hemoglobin drop. 3. Need for transfusion of packed red blood cells for procedure-related bleeding while in the study. The secondary endpoints of this study will be: 1) The need to perform subsequent procedures (angiography, embolization, additional imaging study including computerized tomography (CT) scan, surgery) to diagnose or to arrest procedure-related bleeding OR the need for subsequent medical therapies (FFP, coagulation factor concentrates, anti-fibrinolytics) to treat procedure-related bleeding between time of procedure and the end of patient's time in the study. If necessary, the relationship of procedure or therapy to procedure-related bleeding will be assessed by an adjudication panel; 2) The predictive value of INR; 3) The effect of study treatment on change in INR; 4) The cost of preventing one bleed; 5) The predictors of bleeding other than INR; 6) The number of transfusion-associated adverse events encountered to prevent one bleed; and 7) The effect of treatment on bleeding grade.

Key facts

Study ID: NCT00233246
Run by: Massachusetts General Hospital
People needed: 0
Starts: 2006-03-01
Last updated by the study team: 2014-06-06

Who can join

Age: 4 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Emory University — Atlanta, Georgia, United States
University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
University of Maryland Medical Center — Baltimore, Maryland, United States
Johns Hopkins Hospital — Baltimore, Maryland, United States
Massachusetts General Hospital — Boston, Massachusetts, United States
University of Minnesota — Minneapolis, Minnesota, United States
Mayo Clinic — Rochester, Minnesota, United States
Weill Medical College of Cornell University — New York, New York, United States
University of North Carolina Hospital — Chapel Hill, North Carolina, United States
Duke University Medical Center — Durham, North Carolina, United States
University of Pennsylvania — Philadelphia, Pennsylvania, United States
University of Pittsburgh Presbyterian and Shadyside Hospital — Pittsburgh, Pennsylvania, United States
University of Texas SW Medical Center — Dallas, Texas, United States
Puget Sound Blood Center Div of Research — Seattle, Washington, United States
Blood Center of SE Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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