Viscoelastometric-guided early fibrinogen concentrate replacement during postpartum haemorrhage: OBS2, a double-blind randomized controlled trial



Collins, PW, Cannings-John, R, Bruynseels, D, Mallaiah, S, Dick, J, Elton, C, Weeks, AD ORCID: 0000-0002-1909-337X, Sanders, J, Aawar, N, Townson, J
et al (show 3 more authors) (2017) Viscoelastometric-guided early fibrinogen concentrate replacement during postpartum haemorrhage: OBS2, a double-blind randomized controlled trial. BRITISH JOURNAL OF ANAESTHESIA, 119 (3). pp. 411-421.

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Abstract

<h4>Background</h4>Postpartum haemorrhage (PPH) can be exacerbated by haemostatic failure. We hypothesized that early fibrinogen replacement, guided by viscoelastometric testing, reduces blood product usage and bleed size.<h4>Methods</h4>Women with PPH 1000-1500 ml were enrolled. If Fibtem A5 was ≤15 mm and bleeding continued, subjects were randomized to fibrinogen concentrate or placebo. The primary outcome compared the number of units of red blood cells, plasma, cryoprecipitate and platelets transfused.<h4>Results</h4>Of 663 women enrolled 55 were randomized. The adjusted incidence rate ratio (IRR) (95% CI) for the number of allogeneic units transfused in the fibrinogen group compared with placebo was 0.72 (0.3-1.7), P =0.45. In pre-specified subgroup analyses, subjects who had a Fibtem A5 ≤12 mm at the time of randomization and who received fibrinogen concentrate received a median (25th-75th centile) of 1 (0-4.5) unit of allogeneic blood products and had an additional 300 (100-350) ml blood loss whereas those who received placebo also received 3 (0-6) units of allogeneic blood products and had 700 (200-1550) ml additional blood loss; these differences were not statistically significantly different. There was one thrombotic event in each group.<h4>Conclusions</h4>Infusion of fibrinogen concentrate triggered by Fibtem A5 ≤15 mm did not improve outcomes in PPH. Pre-specified subgroup analyses suggest that fibrinogen replacement is not required if the Fibtem A5 is > 12 mm or Clauss fibrinogen >2 g litre -1 , but an effect below these levels cannot be excluded. The raised fibrinogen at term appears to be a physiological buffer rather than required for haemostasis.<h4>Trial registration</h4>ISRCTN46295339 ( http://www.isrctn.com/ISRCTN46295339 , last accessed 5 July 2017), EudraCT 2012-005511-11 ( https://www.clinicaltrialsregister.eu/ctr-search/search?query=2012-005511-11 , last accessed 5 July 2017).

Item Type: Article
Uncontrolled Keywords: fibrinogen, postpartum haemorrhage, viscoelastometry
Depositing User: Symplectic Admin
Date Deposited: 03 Jan 2018 14:17
Last Modified: 19 Jan 2023 06:46
DOI: 10.1093/bja/aex181
Related URLs:
URI: https://livrepository.liverpool.ac.uk/id/eprint/3015358