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Factor VIIa

The Use of Factor VIIa in Trauma Patients:  A Multi-Center Case Registry

The hypothesis for this study is that early administration of a large, single dose of Factor VIIa in hemodynamically unstable trauma patients will significantly reduce total blood loss and allow faster correction of hemorrhagic shock.

This two year study, funded by the Western Trauma Association Foundation, is the first to extensively document the use of rFVIIa in the United States. Its purpose is to shed light on the issues of proper patient selection, the timing and dosing of the product, the cost-benefit (including potentially shorter ICU stays), and associated thrombotic or infectious complications, including MOF.

SFIC coordinates the research by managing the web-based database, recruiting and registering participating centers and coordinating their reimbursements. The Factor VII online registry is a web-based data entry form designed specifically for this study by Aristein Bioinformatics. The site is username and password protected and generates new Subject ID's sequentially as sites log in to enter data. No patient identifiers are kept on the website. Instead, participating centers record the automatically-generated Subject IDs connection to their patients' charts themselves. Additionally, only the coordinating center (SFIC) has access to view all the entries in the form of a database for ease in manipulating the data. The online form allows direct manual data entry of roughly 21 questions and datasets (e.g. lab results) separated into seven sections. Currently, 21 hospital sites around the country have access to the webpage. Current enrollment stands at 755 entries. Data validation is ongoing as corrections are needed on data entered by participating centers for completeness and high quality.  

Participating Sites