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Cited by 267Maternal and fetal healthcareBlood transfusion and managementHemostasis and retained surgical items

Pre-emptive treatment with fibrinogen concentrate for postpartum haemorrhage: randomized controlled trial

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Wikkelsø, A.J., Edwards, H.M., Afshari, A., Stensballe, J., Langhoff-Roos, J., Albrechtsen, C., Ekelund, K., Hanke, G. +60 more·2015·British Journal of Anaesthesia
DOI 10.1093/bja/aeu444
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Abstract

Background In early postpartum haemorrhage (PPH), a low concentration of fibrinogen is associated with excessive subsequent bleeding and blood transfusion. We hypothesized that pre-emptive treatment with fibrinogen concentrate reduces the need for red blood cell (RBC) transfusion in patients with PPH.Methods In this investigator-initiated, multicentre, double-blinded, parallel randomized controlled trial, we assigned subjects with severe PPH to a single dose of fibrinogen concentrate or placebo (saline). A dose of 2 g or equivalent was given to all subjects independent of body weight and the fibrinogen concentration at inclusion. The primary outcome was RBC transfusion up to 6 weeks postpartum. Secondary outcomes were total blood loss, total amount of blood transfused, occurrence of rebleeding, haemoglobin <58 g litre(-1), RBC transfusion within 4 h, 24 h, and 7 days, and as a composite outcome of 'severe PPH', defined as a decrease in haemoglobin of >40 g litre(-1), transfusion of at least 4 units of RBCs, haemostatic intervention (angiographic embolization, surgical arterial ligation, or hysterectomy), or maternal death.Results Of the 249 randomized subjects, 123 of 124 in the fibrinogen group and 121 of 125 in the placebo group were included in the intention-to-treat analysis. At inclusion the subjects had severe PPH, with a mean blood loss of 1459 (sd 476) ml and a mean fibrinogen concentration of 4.5 (sd 1.2) g litre(-1). The intervention group received a mean dose of 26 mg kg(-1) fibrinogen concentrate, thereby significantly increasing fibrinogen concentration compared with placebo by 0.40 g litre(-1) (95% confidence interval, 0.15-0.65; P=0.002). Postpartum blood transfusion occurred in 25 (20%) of the fibrinogen group and 26 (22%) of the placebo group (relative risk, 0.95; 95% confidence interval, 0.58-1.54; P=0.88). We found no difference in any predefined secondary outcomes, per-protocol analyses, or adjusted analyses. No thromboembolic events were detected.Conclusions We found no evidence for the use of 2 g fibrinogen concentrate as pre-emptive treatment for severe PPH in patients with normofibrinogenaemia.Clinical trial registration ClinicalTrials.gov: http://clinicaltrials.gov/show/NCT01359878. Published protocol: http://www.trialsjournal.com/content/pdf/1745-6215-13-110.pdf.

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  • A randomized placebo-controlled trial of 249 subjects found that preemptive fibrinogen concentrate did not reduce the risk of blood transfusion in bleeding pregnant patients with hypofibrinogenemia.

    “However, a randomized, placebo-controlled trial explored the preemptive use of fibrinogen concentrates in bleeding pregnant patients with hypofibrinogenemia (106). The study, which included 249 subjects, found that preemptive use did not reduce the risk of blood transfusion.”

    From Placental abruption at near-term and term gestations: Pathophysiology, epidemiology, diagnosis, and management (2023) · cites this paper as [106]

    The Abstract and Outcome and adverse events report that this randomized, placebo-controlled trial enrolled 249 subjects and found no reduction in red blood cell transfusion with pre-emptive fibrinogen concentrate. But the Study population section reports a mean baseline fibrinogen concentration of 4.5 g/litre, with only 2.2% below 2 g/litre; the Abstract describes the patients as having normofibrinogenaemia. The claim's characterization of the trial population as patients with hypofibrinogenemia is therefore not supported. (LLM, conf=0.92)

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Authors
Wikkelsø, A. J., Edwards, H. M., Afshari, A., Stensballe, J., Langhoff-Roos, J., Albrechtsen, C., Ekelund, K., Hanke, G., Secher, E. L., Sharif, H. F., Pedersen, L. M., Troelstrup, A., Lauenborg, J., Mitchell, A. U., Fuhrmann, L., Svare, J., Madsen, M. G., Bødker, B., Møller, A. M., Wikkelsø, A., Edwards, H., Afshari, A., Stensballe, J., Langhoff-Roos, J., Møller, A. M., Albrechtsen, C., Ekelund, K., Hanke, G., Sharif, H. F., Secher, E. L., Christensen, M., Ramsing, B. U., Jensen-Gadegaard, P., Engskov, A., Wulff, C., Berntsen, M., Andersen, K. J., Classen, V., Opstrup, P., Lundstrøm, L. H., Flindt, M. S., Lunde, J., Pedersen, L. M., Troelstrup, A., Lauenborg, J., Lassen, B., Andersson, M., Winther-Olsen, M., Hougaard, S., Andersen, C., Petersen, M., Mitchell, A., Fuhrmann, L., Svare, J., Nielsen, C. V., Lefort Sønderskov, M., Winkel, R., Johansen, M., Søgaard, M., Madsen, M. G., Bødker, B., Okkels, C., Berthelsen, R., Elisabeth Linnet, K., Stendall, L., Darfeld, I., Madsen, M., & Pedersen, L.
Affiliations
University of Copenhagen (DK)
Corresponding author
Wikkelsø, A.J.
ORCID
Venue
British Journal of Anaesthesia
Publisher
Elsevier BV
Published
2015-04
Volume
114
Issue
4
Pages
623-633
ISSN
0007-0912 (ISSN-L)
DOI
10.1093/bja/aeu444
OpenAlex
W2140967888
Cited by
267
References
25
Citations by year
2026: 19 · 2025: 18 · 2024: 25 · 2023: 24 · 2022: 20 · 2021: 19 · 2020: 18 · 2019: 23 · 2018: 21 · 2017: 32 · 2016: 27 · 2015: 21
FWCI
33.54
Type
journal article
Language
en
Open access
Licence
Locations
  • British Journal of Anaesthesia (publishedVersion)
  • PubMed (publishedVersion)
  • Research at the University of Copenhagen (University of Copenhagen) (submittedVersion)
Funders
  • The Danish (10-084494)
  • Council for Independent Research (17-12-1981)
  • | Medical sciences
  • Region Hovedstadens Sundhedsvidenskabelige Forskningsfond; Forskningsrådet Herlev Hospital
  • Laerdals Acute Foundation; Aase og Ejnar Danielsens Fond
Topics
  • Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Maternal and fetal healthcare
  • Health Sciences › Medicine › Biochemistry › Blood transfusion and management
  • Health Sciences › Medicine › Hematology › Hemostasis and retained surgical items
Keywords
postpartum hemorrhage, fibrinogen concentrate, preemptive therapy, red blood cell transfusion, fibrinogen, rebleeding, hemoglobin, blood loss, maternal mortality, thromboembolic events, obstetric hemorrhage management, hysterectomy, angiographic embolization, thrombocytopenia, thrombocytopenic purpura, thrombocytopenic thrombosis
MeSH terms
Double-Blind Method, Female, Fibrinogen, Postpartum Hemorrhage, Hemostasis, Humans, Pregnancy, Treatment Outcome, Erythrocyte Transfusion

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