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

Collins, P. W. ORCID:, Cannings-John, R. ORCID:, Bruynseels, D., Mallaiah, S., Dick, J., Elton, C., Weeks, A. D., Sanders, J. ORCID:, Aawar, N., Townson, J. ORCID:, Hood, K. ORCID:, Hall, J. E. ORCID: and Collis, R. E. 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. 10.1093/bja/aex181

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Background: 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. Methods: 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. Results: 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. Conclusions: 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

Item Type: Article
Date Type: Publication
Status: Published
Schools: Healthcare Sciences
Subjects: R Medicine > R Medicine (General)
Additional Information: On behalf the OBS2 study team
Publisher: Elsevier
ISSN: 0007-0912
Funders: CSL Behring
Date of First Compliant Deposit: 19 June 2017
Date of Acceptance: 25 May 2017
Last Modified: 02 May 2023 16:54

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