Use of fibrin monomer complex for screening for venous thromboembolism in the late pregnancy and post‐partum period

Kawamura, Makoto; Fukuda, Naoko; Suzuki, Ayako; Kobayashi, Yusuke; Matsuda, Miho; Kanda, Rieko; Kiseki, Hisami; Tsukahara, Yutaka; Hashimura, Naohiko

doi:10.1111/jog.12245

Cited by 7 publications

(10 citation statements)

References 16 publications

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“…Several studies have looked at recording D-dimer reference intervals during the three trimesters in healthy pregnancy and suggested pregnancy-associated cut-off levels that may assist clinical decision-making on VTE prophylaxis [23, 24]. Soluble fibrin monomer forms a complex with fibrinogen in the bloodstream early in coagulation, and measuring levels of the complex has also been proposed as a marker to screen for VTE [25]. However, recent studies have questioned the predictive utility of all conventional and candidate VTE biomarkers for use during pregnancy and the puerperium [26, 27].…”

Section: Methodsmentioning

confidence: 99%

Evaluation of unmet clinical needs in prophylaxis and treatment of venous thromboembolism in at-risk patient groups: pregnancy, elderly and obese patients

et al. 2019

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BackgroundVenous thromboembolism (VTE) accounts for an estimated 900,000 cases per year in the US alone and constitutes a considerable burden on healthcare systems across the globe.ObjectiveTo understand why the burden is so high, qualitative and quantitative research was carried out to gain insights from experts, guidelines and published studies on the unmet clinical needs and therapeutic strategies in VTE prevention and treatment in three populations identified as being at increased risk of VTE and in whom VTE prevention and treatment were regarded as suboptimal: pregnant women, the elderly and obese patients.MethodologyA gap analysis methodology was created to highlight unmet needs in VTE management and to discover the patient populations considered most at risk. A questionnaire was devised to guide qualitative interviews with 44 thrombosis and haemostasis experts, and a review of the literature on VTE in the specific patient groups from 2015 to 2017 was completed. This was followed by a Think Tank meeting where the results from the research were discussed.ResultsThis review highlights the insights gained and examines in detail the unmet needs with regard to VTE risk-assessment tools, biomarkers, patient stratification methods, and anticoagulant and dosing regimens in pregnant women, the elderly and obese patients.ConclusionsSpecifically, in pregnant women at high risk of VTE, low-molecular-weight heparin (LMWH) is the therapy of choice, but it remains unclear how to use anticoagulants when VTE risk is intermediate. In elderly patients, evaluation of the benefit of VTE prophylaxis against the bleeding risk is particularly important, and a head-to-head comparison of efficacy and safety of LMWH versus direct oral anticoagulants is needed. Finally, in obese patients, lack of guidance on anticoagulant dose adjustment to body weight has emerged as a major obstacle in effective prophylaxis and treatment of VTE.

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Section: Methodsmentioning

confidence: 99%

Evaluation of unmet clinical needs in prophylaxis and treatment of venous thromboembolism in at-risk patient groups: pregnancy, elderly and obese patients

et al. 2019

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“…The reason for the conflicting data regarding FM stability during pregnancy in earlier studies 13–17 is difficult to explain. Three studies have, as in the present report, included measurements from the same pregnant women throughout pregnancy and postpartum.…”

Section: Discussionmentioning

confidence: 96%

“…16 The other studies on FM have not followed the same women throughout pregnancy, and in these publications, no or minimal increase in FM concentrations was identified. 13–15…”

Section: Discussionmentioning

confidence: 99%

“…1–3,6–8 FM could be especially valuable in clinical conditions where DD is elevated, without the presence of VTE, for example after surgery 9–12 or in pregnancy. 13–15 In pregnancy, FM could be a more useful marker than DD, since it is more closely related to thrombin activity rather than fibrinolysis. 3 There are conflicting results regarding the stability of FM concentrations throughout pregnancy.…”

Section: Introductionmentioning

confidence: 99%

“…3 There are conflicting results regarding the stability of FM concentrations throughout pregnancy. 2,13–18 There are no studies estimating biological variation of FM in pregnant or in non-pregnant women. The aim of the present study was to describe the main course of FM throughout pregnancy and postpartum in the same healthy pregnant women and compare the estimated biological variation with healthy non-pregnant women during a similar time course.…”

Section: Introductionmentioning

confidence: 99%

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Concentration of fibrin monomer in pregnancy and during the postpartum period

et al. 2019

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Background D-dimer increases during pregnancy and is problematic to use in the diagnosis of venous thromboembolism. Fibrin monomer represents an alternative biomarker for venous thromboembolism. However, to be useful in pregnancy, the fibrin monomer concentration should be stable throughout pregnancy and during postpartum. Methods To describe the course of fibrin monomer concentration during pregnancy and the postpartum period in healthy pregnant women and to compare their within-subject biological variation (CVI) with non-pregnant women. Blood samples were obtained every fourth week during pregnancy and three samples after delivery in 20 healthy women and every fourth week during a 40-week period in 19 healthy non-pregnant women. Fibrin monomer (STA Liatest FM, Stago) was analysed in duplicates for all samples. Concentrations of fibrin monomer in pregnant and non-pregnant women were compared and the CVI for fibrin monomer was calculated. Results The median fibrin monomer concentration in pregnant women was 6.2 mg/L (2.5 and 97.5 percentiles 3.7–10.8 mg/L) and in non-pregnant women 4.8 mg/L (3.6–8.2) ( P < 0.01). The fibrin monomer concentration was relatively stable during pregnancy, although a few unexplained high fibrin monomer concentrations were found during pregnancy/postpartum. Fibrin monomer CVI in pregnancy and postpartum was 20.6% (95% CI 18.3, 23.5) and in non-pregnant 16.1% (13.7, 18.9). Conclusions For clinical purposes, fibrin monomer concentration can be considered stable during pregnancy, although it is slightly higher than in non-pregnant women. Pregnant and non-pregnant women have the same CVI. The suitability of fibrin monomer in venous thromboembolism diagnosis in pregnant women should be validated in further studies.

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Maternal and pregnancy characteristics affect plasma fibrin monomer complexes and D-dimer reference ranges for venous thromboembolism in pregnancy

Grossman

Arya

Peixoto

et al. 2016

American Journal of Obstetrics and Gynecology

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Use of fibrin monomer complex for screening for venous thromboembolism in the late pregnancy and post‐partum period

Abstract: FMC levels could identify pregnancy-related abnormalities requiring compression ultrasonography examination, without changing the cut-off values for non-pregnant individuals. Thus, this marker may be used to screen for VTE.

Cited by 7 publications

References 16 publications

Evaluation of unmet clinical needs in prophylaxis and treatment of venous thromboembolism in at-risk patient groups: pregnancy, elderly and obese patients

Evaluation of unmet clinical needs in prophylaxis and treatment of venous thromboembolism in at-risk patient groups: pregnancy, elderly and obese patients

Concentration of fibrin monomer in pregnancy and during the postpartum period

Maternal and pregnancy characteristics affect plasma fibrin monomer complexes and D-dimer reference ranges for venous thromboembolism in pregnancy

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