Status:
WITHDRAWN
Fresh-Frozen Plasma Infusions to Reduce Risk of Bleeding Related to Invasive Procedures
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Transfusion Medicine/Hemostasis Clinical Research Network
Conditions:
Blood Coagulation Disorders
Eligibility:
All Genders
4+ years
Phase:
PHASE3
Brief Summary
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 n...
Detailed Description
BACKGROUND: It is important to determine whether or not prophylactic FFP is necessary for patients with mild to moderate elevation of the INR who require an invasive procedure. It is also important t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00233246
Start Date
March 1 2006
Last Update
June 6 2014
Active Locations (15)
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1
Emory University
Atlanta, Georgia, United States, 30322
2
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
3
University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
4
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287