Sarah F. Bell, Hazel Taylor, Philip Pallmann, Peter Collins, the OBS Cymru collaborators (online Supporting Information Appendix S1)
<p>Fibrinogen is essential for haemostasis and can fall to critically low levels in acute haemorrhage [<span>1</span>]. The long turnaround time for laboratory Clauss fibrinogen has led to interest in point-of-care viscoelastic haemostatic assays to identify hypofibrinogenemia. The ROTEM® Delta and Sigma devices (Werfen, Warrington, UK) offer the FIBTEM assay to assess fibrinogen contribution to clot strength in whole blood. FIBTEM A5, the amplitude 5 min after the clotting time, is used as a surrogate for the Clauss fibrinogen in management algorithms [<span>2, 3</span>]. The original FIBTEM assay used Cytochalasin D to inhibit platelets although inhibition was found to be partially influenced by the platelet count [<span>4</span>]. Tirofiban, a glycoprotein 2b/3a receptor antagonist, was added to reduce the influence of platelets and the dual platelet-inhibited assay received regulatory approval in 2022 [<span>5</span>].</p><p>Guidelines recommend that fibrinogen levels should be maintained > 2 g.l<sup>-1</sup> [<span>6, 7</span>] in obstetric haemorrhage. Since 2017, management of postpartum haemorrhage in Wales has followed the OBS Cymru ROTEM® algorithm [<span>3</span>] with a FIBTEM A5 > 11 mm corresponding to a Clauss fibrinogen of approximately 2 g.l<sup>-1</sup>. In April 2023, Sigma cartridges with the dual platelet-inhibited FIBTEM assay were distributed in the UK. Clinicians at our institution became aware of this change in July 2024 following anecdotal observations of an altered relationship between FIBTEM A5 and Clauss fibrinogen, and discussions with the manufacturer.</p><p>Following local service evaluation registration, anonymised data were collected retrospectively from five obstetric units in Wales using the dual platelet-inhibited FIBTEM assay. In total, 212 paired FIBTEM and Clauss fibrinogen results were available for analysis with some patients having more than one sample during a single postpartum haemorrhage episode. Four samples from a patient with severe liver impairment were excluded. The utility of the dual platelet-inhibited FIBTEM A5 to distinguish Clauss fibrinogen ≤ 2 g.l<sup>-1</sup> was analysed. Fibrinogen ≤ 2 g.l<sup>-1</sup> is uncommon during postpartum haemorrhage and to obtain sufficient data around this level, purposive data collection was necessary (Fig. 1). Comparison was made with data from a previous study which used single platelet-inhibited Sigma FIBTEM assays [<span>1</span>].</p><p>There was a stronger linear correlation between FIBTEM A5 and Clauss fibrinogen (r = 0.88) (Fig. 1) in the dual platelet-inhibited FIBTEM assay compared with data from a single platelet-inhibited assay (r = 0.63) [<span>8</span>]. With the dual platelet-inhibited assay, FIBTEM A5 of 11 mm (as used in the algorithm with the single platelet-inhibited assay [<span>3</span>]) corresponded to a Clauss fibrinogen of 3.05 g.l<sup>-1</sup>, while FIBTEM A5 of 7.8 mm corresponded to a Clauss fibrinogen of 2 g.l<sup>-1</sup
{"title":"Relationship between the dual platelet-inhibited ROTEM® Sigma FIBTEM assay and Clauss fibrinogen during postpartum haemorrhage","authors":"Sarah F. Bell, Hazel Taylor, Philip Pallmann, Peter Collins, the OBS Cymru collaborators (online Supporting Information Appendix S1)","doi":"10.1111/anae.16455","DOIUrl":"10.1111/anae.16455","url":null,"abstract":"<p>Fibrinogen is essential for haemostasis and can fall to critically low levels in acute haemorrhage [<span>1</span>]. The long turnaround time for laboratory Clauss fibrinogen has led to interest in point-of-care viscoelastic haemostatic assays to identify hypofibrinogenemia. The ROTEM® Delta and Sigma devices (Werfen, Warrington, UK) offer the FIBTEM assay to assess fibrinogen contribution to clot strength in whole blood. FIBTEM A5, the amplitude 5 min after the clotting time, is used as a surrogate for the Clauss fibrinogen in management algorithms [<span>2, 3</span>]. The original FIBTEM assay used Cytochalasin D to inhibit platelets although inhibition was found to be partially influenced by the platelet count [<span>4</span>]. Tirofiban, a glycoprotein 2b/3a receptor antagonist, was added to reduce the influence of platelets and the dual platelet-inhibited assay received regulatory approval in 2022 [<span>5</span>].</p><p>Guidelines recommend that fibrinogen levels should be maintained > 2 g.l<sup>-1</sup> [<span>6, 7</span>] in obstetric haemorrhage. Since 2017, management of postpartum haemorrhage in Wales has followed the OBS Cymru ROTEM® algorithm [<span>3</span>] with a FIBTEM A5 > 11 mm corresponding to a Clauss fibrinogen of approximately 2 g.l<sup>-1</sup>. In April 2023, Sigma cartridges with the dual platelet-inhibited FIBTEM assay were distributed in the UK. Clinicians at our institution became aware of this change in July 2024 following anecdotal observations of an altered relationship between FIBTEM A5 and Clauss fibrinogen, and discussions with the manufacturer.</p><p>Following local service evaluation registration, anonymised data were collected retrospectively from five obstetric units in Wales using the dual platelet-inhibited FIBTEM assay. In total, 212 paired FIBTEM and Clauss fibrinogen results were available for analysis with some patients having more than one sample during a single postpartum haemorrhage episode. Four samples from a patient with severe liver impairment were excluded. The utility of the dual platelet-inhibited FIBTEM A5 to distinguish Clauss fibrinogen ≤ 2 g.l<sup>-1</sup> was analysed. Fibrinogen ≤ 2 g.l<sup>-1</sup> is uncommon during postpartum haemorrhage and to obtain sufficient data around this level, purposive data collection was necessary (Fig. 1). Comparison was made with data from a previous study which used single platelet-inhibited Sigma FIBTEM assays [<span>1</span>].</p><p>There was a stronger linear correlation between FIBTEM A5 and Clauss fibrinogen (r = 0.88) (Fig. 1) in the dual platelet-inhibited FIBTEM assay compared with data from a single platelet-inhibited assay (r = 0.63) [<span>8</span>]. With the dual platelet-inhibited assay, FIBTEM A5 of 11 mm (as used in the algorithm with the single platelet-inhibited assay [<span>3</span>]) corresponded to a Clauss fibrinogen of 3.05 g.l<sup>-1</sup>, while FIBTEM A5 of 7.8 mm corresponded to a Clauss fibrinogen of 2 g.l<sup>-1</sup","PeriodicalId":7742,"journal":{"name":"Anaesthesia","volume":"80 1","pages":"104-106"},"PeriodicalIF":7.5,"publicationDate":"2024-10-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/anae.16455","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142490163","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Rafael S. F. Nersessian, Leopoldo M. da Silva, Marco Aurélio S. Carvalho, Saullo Q. Silveira, Arthur C. V. Abib, Fernando N. Bellicieri, Helidea O. Lima, Anthony M.-H. Ho, Gabriel S. Anjos, Glenio B. Mizubuti