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Functional fibrinogen (FLEV-TEG) versus the Clauss method in an obstetric population: a comparative study

BACKGROUND: Hemostasis is the dynamic equilibrium between coagulation and fibrinolysis. During pregnancy, the balance shifts toward a hypercoagulative state; however placental abruption and abnormal placentations may lead to rapidly evolving coagulopathy characterized by the increased activation of...

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Autores principales: Spasiano, Alessandra, Matellon, Carola, Orso, Daniele, Brussa, Alessandro, Cafagna, Maria, Marangone, Anna, Dogareschi, Teresa, Bove, Tiziana, Giacomello, Roberta, Fontana, Desrè, Vetrugno, Luigi, Della Rocca, Giorgio
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6545203/
https://www.ncbi.nlm.nih.gov/pubmed/31153366
http://dx.doi.org/10.1186/s12871-019-0769-8
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author Spasiano, Alessandra
Matellon, Carola
Orso, Daniele
Brussa, Alessandro
Cafagna, Maria
Marangone, Anna
Dogareschi, Teresa
Bove, Tiziana
Giacomello, Roberta
Fontana, Desrè
Vetrugno, Luigi
Della Rocca, Giorgio
author_facet Spasiano, Alessandra
Matellon, Carola
Orso, Daniele
Brussa, Alessandro
Cafagna, Maria
Marangone, Anna
Dogareschi, Teresa
Bove, Tiziana
Giacomello, Roberta
Fontana, Desrè
Vetrugno, Luigi
Della Rocca, Giorgio
author_sort Spasiano, Alessandra
collection PubMed
description BACKGROUND: Hemostasis is the dynamic equilibrium between coagulation and fibrinolysis. During pregnancy, the balance shifts toward a hypercoagulative state; however placental abruption and abnormal placentations may lead to rapidly evolving coagulopathy characterized by the increased activation of procoagulant pathways. These processes can result in hypofibrinogenemia, with fibrinogen levels dropping to 2 g/L or less and an associated increased risk of post-partum hemorrhage. The aim of the present study was to evaluate the concordance between two methods of functional fibrinogen measurement: the Thromboelastography (TEG) method (also known as FLEV) vs. the Clauss method. Three patient groups were considered: healthy volunteers; non-pathological pregnant patients; and pregnant patients who went on to develop postpartum hemorrhage. METHODS: A prospective observational study. Inclusion criteria were: healthy volunteer women of childbearing age, non-pathological pregnant women at term, and pregnant hemorrhagic patients subjected to elective or urgent caesarean section (CS), with blood loss exceeding 1000 mL. Exclusion criteria were age < 18 years, a history of coagulopathy, and treatment with contraceptives, anticoagulants, or antiplatelet agents. RESULTS: Bland-Altman plots showed a significant overestimation with the FLEV method in all three patient groups: bias was − 133.36 mg/dL for healthy volunteers (95% IC: − 257.84; − 8.88. Critical difference: 124.48); − 56.30 mg/dL for healthy pregnant patients (95% IC: − 225.53; 112.93. Critical difference: 169.23); and − 159.05 mg/dL for hemorrhagic pregnant patients (95% IC: − 333.24; 15.148. Critical difference: 174.19). Regression analyses detected a linear correlation between FLEV and Clauss for healthy volunteers, healthy pregnant patients, and hemorrhagic pregnant patients (R(2) 0.27, p value = 0.002; R(2) 0.31, p value = 0.001; R(2) 0.35, p value = 0.001, respectively). ANOVA revealed a statistically significant difference in fibrinogen concentration between all three patients groups when assayed using the Clauss method (p value < 0.001 for all the comparisons), but no statistically significant difference between the two patients groups of pregnant women when using the FLEV method. CONCLUSIONS: The FLEV method does not provide a valid alternative to the Clauss method due to the problem of fibrinogen overestimation, and for this reason it should not be recommended for the evaluation of patients with an increased risk of hypofibrinogenemia.
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spelling pubmed-65452032019-06-05 Functional fibrinogen (FLEV-TEG) versus the Clauss method in an obstetric population: a comparative study Spasiano, Alessandra Matellon, Carola Orso, Daniele Brussa, Alessandro Cafagna, Maria Marangone, Anna Dogareschi, Teresa Bove, Tiziana Giacomello, Roberta Fontana, Desrè Vetrugno, Luigi Della Rocca, Giorgio BMC Anesthesiol Research Article BACKGROUND: Hemostasis is the dynamic equilibrium between coagulation and fibrinolysis. During pregnancy, the balance shifts toward a hypercoagulative state; however placental abruption and abnormal placentations may lead to rapidly evolving coagulopathy characterized by the increased activation of procoagulant pathways. These processes can result in hypofibrinogenemia, with fibrinogen levels dropping to 2 g/L or less and an associated increased risk of post-partum hemorrhage. The aim of the present study was to evaluate the concordance between two methods of functional fibrinogen measurement: the Thromboelastography (TEG) method (also known as FLEV) vs. the Clauss method. Three patient groups were considered: healthy volunteers; non-pathological pregnant patients; and pregnant patients who went on to develop postpartum hemorrhage. METHODS: A prospective observational study. Inclusion criteria were: healthy volunteer women of childbearing age, non-pathological pregnant women at term, and pregnant hemorrhagic patients subjected to elective or urgent caesarean section (CS), with blood loss exceeding 1000 mL. Exclusion criteria were age < 18 years, a history of coagulopathy, and treatment with contraceptives, anticoagulants, or antiplatelet agents. RESULTS: Bland-Altman plots showed a significant overestimation with the FLEV method in all three patient groups: bias was − 133.36 mg/dL for healthy volunteers (95% IC: − 257.84; − 8.88. Critical difference: 124.48); − 56.30 mg/dL for healthy pregnant patients (95% IC: − 225.53; 112.93. Critical difference: 169.23); and − 159.05 mg/dL for hemorrhagic pregnant patients (95% IC: − 333.24; 15.148. Critical difference: 174.19). Regression analyses detected a linear correlation between FLEV and Clauss for healthy volunteers, healthy pregnant patients, and hemorrhagic pregnant patients (R(2) 0.27, p value = 0.002; R(2) 0.31, p value = 0.001; R(2) 0.35, p value = 0.001, respectively). ANOVA revealed a statistically significant difference in fibrinogen concentration between all three patients groups when assayed using the Clauss method (p value < 0.001 for all the comparisons), but no statistically significant difference between the two patients groups of pregnant women when using the FLEV method. CONCLUSIONS: The FLEV method does not provide a valid alternative to the Clauss method due to the problem of fibrinogen overestimation, and for this reason it should not be recommended for the evaluation of patients with an increased risk of hypofibrinogenemia. BioMed Central 2019-06-01 /pmc/articles/PMC6545203/ /pubmed/31153366 http://dx.doi.org/10.1186/s12871-019-0769-8 Text en © The Author(s). 2019 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Research Article
Spasiano, Alessandra
Matellon, Carola
Orso, Daniele
Brussa, Alessandro
Cafagna, Maria
Marangone, Anna
Dogareschi, Teresa
Bove, Tiziana
Giacomello, Roberta
Fontana, Desrè
Vetrugno, Luigi
Della Rocca, Giorgio
Functional fibrinogen (FLEV-TEG) versus the Clauss method in an obstetric population: a comparative study
title Functional fibrinogen (FLEV-TEG) versus the Clauss method in an obstetric population: a comparative study
title_full Functional fibrinogen (FLEV-TEG) versus the Clauss method in an obstetric population: a comparative study
title_fullStr Functional fibrinogen (FLEV-TEG) versus the Clauss method in an obstetric population: a comparative study
title_full_unstemmed Functional fibrinogen (FLEV-TEG) versus the Clauss method in an obstetric population: a comparative study
title_short Functional fibrinogen (FLEV-TEG) versus the Clauss method in an obstetric population: a comparative study
title_sort functional fibrinogen (flev-teg) versus the clauss method in an obstetric population: a comparative study
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6545203/
https://www.ncbi.nlm.nih.gov/pubmed/31153366
http://dx.doi.org/10.1186/s12871-019-0769-8
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