Overview

Open Label Use Of RiaStap During Aortic Reconstruction

Status:
Completed
Trial end date:
2012-12-01
Target enrollment:
Participant gender:
Summary
The overall purpose of this study is to administer fibrinogen concentrate (RiaSTAP, CSL Behring, Marburg, Germany) with the goal of treating coagulopathic bleeding by improving hemostasis thereby reducing overall blood product transfusion after separation from cardiopulmonary bypass following aortic reconstructive surgery. With the current sample size this is a pilot study and in effect will determine the fibrinogen level response to fibrinogen concentrate administered during aortic reconstructive surgery. It will be underpowered to detect reduction in bleeding but comparison to historical controls will be included as a secondary outcome.
Phase:
Phase 4
Details
Lead Sponsor:
Duke University
Collaborator:
CSL Behring