A Feasibility Study of Thromboembolic Events and All-Cause Mortality among Patients Treated with Beriplex or Plasma for VKA Reversal

Beriplex is a 4-factor prothrombin complex concentrate (PCC) that has been available outside the U.S. for a number of years and is expected to be approved by the FDA in 2013.  The FDA has requested postmarketing surveillance (PMS) to determine whether thromboembolic events (TEEs) and deaths occur with greater frequency among patients treated with Beriplex for vitamin K antagonist (VKA) reversal compared with those treated with plasma (the current standard treatment in the U.S.).  The main source of data will be the Premier Hospital Database, which contains de-identified information on diagnoses and treatments for patients in more than 600 hospitals, covering approximately one-fifth of U.S. hospitalizations.  If feasible, patients will be monitored for 30 days after VKA reversal, a portion of which will be post-discharge.  The surveillance program will be conducted in three phases:  1) a two-part feasibility study, which will include a detailed investigation, with medical record review, of 30 patients treated with plasma before Beriplex is available, and a database-only analysis of all VKA reversal patients in the Premier database from January 2010 to June 2012; 2) a pilot study, in which 30 patients treated with Beriplex will be compared with 30 patients treated with plasma in hospitals where Beriplex is not used, and a larger scale database-only analysis will be conducted; 3) the main study, in which it is currently anticipated that 500 Beriplex patients will be compared with 500 plasma patients.

Investigators and Study Staff

Investigator:

David W. Kaufman, Sc.D., Principal Investigator

Study Staff:

Judith P. Kelly, M.S., Epidemiologist
Fiona Rice, M.P.H., Project Coordinator

Study Details

Source of Funding:

CSL Behring

Study Period:

2012 to 2013

Contact Information

David W. Kaufman, Sc.D., at 617-734-6006 or dwk@bu.edu