Collins, P. W.  ORCID: https://orcid.org/0000-0002-6410-1324, Cannings-John, R. ORCID: https://orcid.org/0000-0001-5235-6517, Bruynseels, D., Mallaiah, S., Dick, J., Elton, C., Weeks, A. D., Sanders, J. ORCID: https://orcid.org/0000-0001-5712-9989, Aawar, N., Townson, J. ORCID: https://orcid.org/0000-0001-8679-3619, Hood, K. ORCID: https://orcid.org/0000-0002-5268-8631, Hall, J. E. ORCID: https://orcid.org/0000-0002-6770-7372 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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Abstract
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 Medicine |
| 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: | 20 Jan 2024 14:42 |
| URI: | https://orca.cardiff.ac.uk/id/eprint/101518 |
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