Authors
Jeannie Callum, Michael E Farkouh, Damon C Scales, Nancy M Heddle, Mark Crowther, Vivek Rao, Hans-Peter Hucke, Jo Carroll, Deep Grewal, Sukhpal Brar, Jean Bussières, Hilary Grocott, Christopher Harle, Katerina Pavenski, Antoine Rochon, Tarit Saha, Lois Shepherd, Summer Syed, Diem Tran, Daniel Wong, Michelle Zeller, Keyvan Karkouti, FIBRES Research Group
Publication date
2019/11/26
Journal
Jama
Volume
322
Issue
20
Pages
1966-1976
Publisher
American Medical Association
Description
Importance
Excessive bleeding is a common complication of cardiac surgery. An important cause of bleeding is acquired hypofibrinogenemia (fibrinogen level <1.5-2.0 g/L), for which guidelines recommend fibrinogen replacement with cryoprecipitate or fibrinogen concentrate. The 2 products have important differences, but comparative clinical data are lacking.
Objective
To determine if fibrinogen concentrate is noninferior to cryoprecipitate for treatment of bleeding related to hypofibrinogenemia after cardiac surgery.
Design, Setting, and Participants
Randomized clinical trial at 11 Canadian hospitals enrolling adult patients experiencing clinically significant bleeding and hypofibrinogenemia after cardiac surgery (from February 10, 2017, to November 1, 2018). Final 28-day follow-up visit was completed on November 28, 2018.
Interventions
Fibrinogen concentrate (4 g; n = 415) or cryoprecipitate (10 units; n = 412) for …
Scholar articles
J Callum, ME Farkouh, DC Scales, NM Heddle… - Jama, 2019