Fibrinogen in the Initial Resuscitation of Severe Trauma (FiiRST) – A Randomized Pilot Feasibility Trial

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Authors
  1. Nascimento, B.
  2. Callum, J.
  3. Tien, H.
  4. Peng, H.
  5. Rizoli, S.
  6. Karanicolas, P.
  7. Alam, A.
  8. Xiong, W.
  9. Selby, R.
  10. Garzon, A.M.
  11. Colavecchia, C.
  12. Howald, R.
Corporate Authors
Defence Research and Development Canada, Toronto Research Centre , Toronto ON (CAN)
Abstract
Objectives: To evaluate the feasibility of a randomized trial, effect on outcomes and complications of early infusion of fibrinogen concentrate(FC) in trauma patients. Background: Fibrinogen is essential for adequate primary and secondary hemostasis. Decreased plasma fibrinogen concentration shortly following injury is associated with higher transfusion needs and mortality. In North America, cryoprecipitate and/or plasma transfusion is the standard of care for fibrinogen supplementation during acute hemorrhage, which often occurs late during trauma resuscitation. Alternatively, FC, a pathogen-inactivated lyophilized product-licensed for congenital hypofibrinogenemia only in Canada and USA-may potentially be beneficial in trauma resuscitation. However, the feasibility of its early infusion, efficacy and safety remains undetermined. Methods: Fifty hypotensive(systolic blood pressure≤100mmHg) adult trauma patients requiring blood transfusion was ordered were randomly assigned to either 6g of FC or placebo between Oct 2014 and Nov 2015 at a tertiary trauma center. The primary outcome, feasibility, was assessed by the proportion of patients receiving the intervention within 1h of hospital arrival. Plasma fibrinogen concentration was compared between study groups. Safety was measured based on 28-day mortality and thromboembolic events. Results: Overall, 95.6%(43/45) [95%CI 86-99%] of patients received the intervention within 1h; 95.2% and 95.8% in the FC and placebo groups, r
Keywords
fibrinogen concentrate;hemorrhage;cryoprecipitate;coagulopathy;trauma
Report Number
DRDC-RDDC-2016-P157 — External Literature
Date of publication
01 Mar 2017
Number of Pages
21
DSTKIM No
CA044841
CANDIS No
805214
Format(s):
Electronic Document(PDF)

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