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| Topics > Hemostasis and Thrombosis |
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Topic News Focus
Feb 9, 2010
Reporting by NATAonline staff
Fibrin Sealants: Their Role in Blood-Sparing Surgery Published: May 2008
During the 9th Annual NATA Symposium, a satellite symposium entitled "Fibrin Sealants: Their Role in Blood-Sparing Surgery" addressed the role of topical haemostatic agents in reducing blood loss and transfusion requirements in surgical patients. This symposium, supported by an educational grant from Johnson & Johnson Wound Management, was chaired by Prof. Marcela Contreras and Mr. Peter Earnshaw and featured presentations by Dr. Heidi Doughty and Dr. Dafydd Thomas. To view a podcast of the symposium, please click on the link above.
Important Trasylol Safety Information Published: Nov 2007
On November 5, Bayer announced that it will temporarily suspend worldwide marketing of Trasylol (aprotinin injection) until the final results from the Canadian BART trial have been evaluated. The company elected to take this global action following direction from the German BfArM and requests from the FDA, Health Canada and other regulators that Bayer temporarily suspend Trasylol marketing in their respective countries until final BART data were available. The BART trial, a randomized controlled trial in high-risk cardiac surgery patients, was halted after a planned periodic data analysis showed reduced bleeding but also increased all-cause mortality in patients who received aprotinin compared to patients who received either epsilon-aminocaproic acid or tranexamic acid.
Safety of Aprotinin in Cardiac Surgery Published: Oct 2006
Since January, 2006, the US FDA has been conducting a safety review of Trasylol (aprotinin injection). The review was triggered by the results of two published research studies: one that reported an increase in the chance of kidney failure, heart attack and stroke in patients treated with Trasylol compared to those treated with other similar drugs, and the other that reported an increase in kidney dysfunction compared to another drug. On September 21, 2006, FDA held a public meeting of the Cardiovascular and Renal Drugs Advisory Committee to discuss the safety and overall risk-benefit profile for Trasylol. At that meeting, the committee discussed the findings from the two published observational studies, the Bayer worldwide safety review, and the FDA review of its own post-marketing database.
On September 27, 2006, Bayer Pharmaceuticals told FDA that it had conducted an additional safety study of Trasylol. The preliminary findings from this new observational study of patients from a hospital database reported that use of Trasylol may increase the chance for death, serious kidney damage, congestive heart failure and strokes. FDA was not aware of these new data when it held the September 21, 2006, Advisory Committee meeting on Trasylol safety. FDA is actively evaluating these new data and their implications for appropriate use of the drug.
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Reviewed Articles
Important articles reviewed by the NATAonline editors
Fawzy H, Elmistekawy E, Bonneau D, Latter D, Errett L
Published: Jun 2009
Can local application of Tranexamic acid reduce post- coronary bypass surgery blood loss? A randomized controlled trial.
J Cardiothorac Surg 2009;4(1):25.
  
 This is an interesting article searching for new ways to save blood in cardiac surgery. Although the number of patients is ...
Reviewed by:J. V. Llau
Westbrook AJ, Olsen J, Bailey M, Bates J, Scully M, Salamonsen RF
Published: Dec 2008
Protocol based on thromboelastograph (TEG) out-performs physician preference using laboratory coagulation tests to guide blood replacement during and after cardiac surgery: a pilot study.
Heart Lung Circ 2008 Dec 29. [Epub ahead of print].
The authors investigated the impact of a TEG-based algorithm for the management of bleeding in cardiac patients. Although ...
Reviewed by:S. Kozek-Langenecker
Mangano DT, Tudor IC, Dietzel C; Multicenter Study of Perioperative Ischemia Research Group; Ischemia Research and Education Foundation
Published: Jan 2006
The risk associated with aprotinin in cardiac surgery.
N Engl J Med 2006;354(4):353-365.
To read the commentary by Dean A. Fergusson, MHA, PhD, from the University of Ottawa Centre for Transfusion Research, please ...
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