Open Label Use Of RiaStap During Aortic Reconstruction

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.

Timeline

Start

2010-12

Primary completion

2012-12

Completion

2012-12

Publications

• Background Rahe-Meyer N, Pichlmaier M, Haverich A, Solomon C, Winterhalter M, Piepenbrock S, Tanaka KA. Bleeding management with fibrinogen concentrate targeting a high-normal plasma fibrinogen level: a pilot study. Br J Anaesth. 2009 Jun;102(6):785-92. doi: 10.1093/bja/aep089. Epub 2009 May 2.
• Background Peyvandi F, Haertel S, Knaub S, Mannucci PM. Incidence of bleeding symptoms in 100 patients with inherited afibrinogenemia or hypofibrinogenemia. J Thromb Haemost. 2006 Jul;4(7):1634-7. doi: 10.1111/j.1538-7836.2006.02014.x. No abstract available.
• Background Rahe-Meyer N, Solomon C, Winterhalter M, Piepenbrock S, Tanaka K, Haverich A, Pichlmaier M. Thromboelastometry-guided administration of fibrinogen concentrate for the treatment of excessive intraoperative bleeding in thoracoabdominal aortic aneurysm surgery. J Thorac Cardiovasc Surg. 2009 Sep;138(3):694-702. doi: 10.1016/j.jtcvs.2008.11.065. Epub 2009 May 17.
• Background Kreuz W et al Tranfus Apheresis Sci 2005; 32: 239-46
• Background Lind P, Hedblad B, Stavenow L, Janzon L, Eriksson KF, Lindgarde F. Influence of plasma fibrinogen levels on the incidence of myocardial infarction and death is modified by other inflammation-sensitive proteins: a long-term cohort study. Arterioscler Thromb Vasc Biol. 2001 Mar;21(3):452-8. doi: 10.1161/01.atv.21.3.452.

Drugs

Indications