The fibrinogen prothrombin time‐derived method is not useful in patients anticoagulated with low molecular weight heparins or rivaroxaban
Essentials Fibrinogen prothrombin time‐derived (FIBPT‐d) behavior in anticoagulated patients is under studied. FIBPT‐d method overestimates fibrinogen in rivaroxaban and low molecular weight heparin samples. Unfractionated heparin and dabigatran samples showed similar bias to the control group. Rabb...
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| Published in: | Journal of thrombosis and haemostasis Vol. 16; no. 8; pp. 1626 - 1631 |
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| Main Authors: | , , , , , , |
| Format: | Journal Article |
| Language: | English |
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Elsevier Limited
01.08.2018
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| ISSN: | 1538-7933, 1538-7836, 1538-7836 |
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| Abstract | Essentials
Fibrinogen prothrombin time‐derived (FIBPT‐d) behavior in anticoagulated patients is under studied.
FIBPT‐d method overestimates fibrinogen in rivaroxaban and low molecular weight heparin samples.
Unfractionated heparin and dabigatran samples showed similar bias to the control group.
Rabbit brain and human recombinant thromboplastin behavior was different in rivaroxaban samples.
Summary
Background
The fibrinogen prothrombin time‐derived (FIBPT‐d) method with photo‐optical coagulometers is easy and economical. However, there are few reports on the behavior of this test on samples from patients anticoagulated with direct oral anticoagulants or low molecular weight heparin (LMWH).
Objective
To compare fibrinogen results obtained with the Clauss (FIB C) method and the FIBPT‐d method with two thromboplastins in anticoagulated patients.
Population
The study population comprised 295 consecutive anticoagulated patients: 99 treated with vitamin K antagonists (VKAs), 49 treated with unfractionated heparin (UFH), 47 treated with LMWH, 50 treated with rivaroxaban, 50 treated with dabigatran, and 100 normal controls (NCs).
Methods
Dabigatran samples were analyzed by the use of FIB C with HemosIL Fibrinogen C or 100 NHI thrombin units mL−1 reagents; rabbit brain and human recombinant thromboplastins with HemosIL PTFibrinogen HS plus (HS) and Recombiplastin 2G (RP) were used for FIBPT‐d method. Heparin and rivaroxaban levels were assessed with HemosIL Liq antiXa with specific calibrators; dabigatran levels were determined with the HemosIL Direct Thrombin Inhibitor Assay. All assays were performed on the ACL TOP platform in two laboratories. Percentage biases for the FIBPT‐d method versus the FIB C method were calculated by the use of Bland–Altman plots.
Results
Positive biases of the FIBPT‐d method versus the FIB C method with both thromboplastins were seen in NC samples (13.7% and 18.9% for HS and RP, respectively), but biases with HS in rivaroxaban and VKA patient samples were higher than that in NC samples, at 31.9% and 34.0%, respectively. LMWH patient samples showed higher bias than NC samples: 26.5% and 29.3.0% with HS and RP, respectively. UFH and dabigatran patient samples showed similar bias as NC samples.
Conclusion
The FIBPT‐d method should not be used in anticoagulated patients, because the FIBPT‐d mathematical algorithm has been validated only in normal subjects, so overestimation could occur in these patients. |
|---|---|
| AbstractList | Essentials
Fibrinogen prothrombin time‐derived (FIBPT‐d) behavior in anticoagulated patients is under studied.
FIBPT‐d method overestimates fibrinogen in rivaroxaban and low molecular weight heparin samples.
Unfractionated heparin and dabigatran samples showed similar bias to the control group.
Rabbit brain and human recombinant thromboplastin behavior was different in rivaroxaban samples.
Summary
Background
The fibrinogen prothrombin time‐derived (FIBPT‐d) method with photo‐optical coagulometers is easy and economical. However, there are few reports on the behavior of this test on samples from patients anticoagulated with direct oral anticoagulants or low molecular weight heparin (LMWH).
Objective
To compare fibrinogen results obtained with the Clauss (FIB C) method and the FIBPT‐d method with two thromboplastins in anticoagulated patients.
Population
The study population comprised 295 consecutive anticoagulated patients: 99 treated with vitamin K antagonists (VKAs), 49 treated with unfractionated heparin (UFH), 47 treated with LMWH, 50 treated with rivaroxaban, 50 treated with dabigatran, and 100 normal controls (NCs).
Methods
Dabigatran samples were analyzed by the use of FIB C with HemosIL Fibrinogen C or 100 NHI thrombin units mL−1 reagents; rabbit brain and human recombinant thromboplastins with HemosIL PTFibrinogen HS plus (HS) and Recombiplastin 2G (RP) were used for FIBPT‐d method. Heparin and rivaroxaban levels were assessed with HemosIL Liq antiXa with specific calibrators; dabigatran levels were determined with the HemosIL Direct Thrombin Inhibitor Assay. All assays were performed on the ACL TOP platform in two laboratories. Percentage biases for the FIBPT‐d method versus the FIB C method were calculated by the use of Bland–Altman plots.
Results
Positive biases of the FIBPT‐d method versus the FIB C method with both thromboplastins were seen in NC samples (13.7% and 18.9% for HS and RP, respectively), but biases with HS in rivaroxaban and VKA patient samples were higher than that in NC samples, at 31.9% and 34.0%, respectively. LMWH patient samples showed higher bias than NC samples: 26.5% and 29.3.0% with HS and RP, respectively. UFH and dabigatran patient samples showed similar bias as NC samples.
Conclusion
The FIBPT‐d method should not be used in anticoagulated patients, because the FIBPT‐d mathematical algorithm has been validated only in normal subjects, so overestimation could occur in these patients. BackgroundThe fibrinogen prothrombin time‐derived (FIBPT‐d) method with photo‐optical coagulometers is easy and economical. However, there are few reports on the behavior of this test on samples from patients anticoagulated with direct oral anticoagulants or low molecular weight heparin (LMWH).ObjectiveTo compare fibrinogen results obtained with the Clauss (FIB C) method and the FIBPT‐d method with two thromboplastins in anticoagulated patients.PopulationThe study population comprised 295 consecutive anticoagulated patients: 99 treated with vitamin K antagonists (VKAs), 49 treated with unfractionated heparin (UFH), 47 treated with LMWH, 50 treated with rivaroxaban, 50 treated with dabigatran, and 100 normal controls (NCs).MethodsDabigatran samples were analyzed by the use of FIB C with HemosIL Fibrinogen C or 100 NHI thrombin units mL−1 reagents; rabbit brain and human recombinant thromboplastins with HemosIL PTFibrinogen HS plus (HS) and Recombiplastin 2G (RP) were used for FIBPT‐d method. Heparin and rivaroxaban levels were assessed with HemosIL Liq antiXa with specific calibrators; dabigatran levels were determined with the HemosIL Direct Thrombin Inhibitor Assay. All assays were performed on the ACL TOP platform in two laboratories. Percentage biases for the FIBPT‐d method versus the FIB C method were calculated by the use of Bland–Altman plots.ResultsPositive biases of the FIBPT‐d method versus the FIB C method with both thromboplastins were seen in NC samples (13.7% and 18.9% for HS and RP, respectively), but biases with HS in rivaroxaban and VKA patient samples were higher than that in NC samples, at 31.9% and 34.0%, respectively. LMWH patient samples showed higher bias than NC samples: 26.5% and 29.3.0% with HS and RP, respectively. UFH and dabigatran patient samples showed similar bias as NC samples.ConclusionThe FIBPT‐d method should not be used in anticoagulated patients, because the FIBPT‐d mathematical algorithm has been validated only in normal subjects, so overestimation could occur in these patients. Essentials Fibrinogen prothrombin time-derived (FIBPT-d) behavior in anticoagulated patients is under studied. FIBPT-d method overestimates fibrinogen in rivaroxaban and low molecular weight heparin samples. Unfractionated heparin and dabigatran samples showed similar bias to the control group. Rabbit brain and human recombinant thromboplastin behavior was different in rivaroxaban samples.Essentials Fibrinogen prothrombin time-derived (FIBPT-d) behavior in anticoagulated patients is under studied. FIBPT-d method overestimates fibrinogen in rivaroxaban and low molecular weight heparin samples. Unfractionated heparin and dabigatran samples showed similar bias to the control group. Rabbit brain and human recombinant thromboplastin behavior was different in rivaroxaban samples.Background The fibrinogen prothrombin time-derived (FIBPT-d) method with photo-optical coagulometers is easy and economical. However, there are few reports on the behavior of this test on samples from patients anticoagulated with direct oral anticoagulants or low molecular weight heparin (LMWH). Objective To compare fibrinogen results obtained with the Clauss (FIB C) method and the FIBPT-d method with two thromboplastins in anticoagulated patients. Population The study population comprised 295 consecutive anticoagulated patients: 99 treated with vitamin K antagonists (VKAs), 49 treated with unfractionated heparin (UFH), 47 treated with LMWH, 50 treated with rivaroxaban, 50 treated with dabigatran, and 100 normal controls (NCs). Methods Dabigatran samples were analyzed by the use of FIB C with HemosIL Fibrinogen C or 100 NHI thrombin units mL-1 reagents; rabbit brain and human recombinant thromboplastins with HemosIL PTFibrinogen HS plus (HS) and Recombiplastin 2G (RP) were used for FIBPT-d method. Heparin and rivaroxaban levels were assessed with HemosIL Liq antiXa with specific calibrators; dabigatran levels were determined with the HemosIL Direct Thrombin Inhibitor Assay. All assays were performed on the ACL TOP platform in two laboratories. Percentage biases for the FIBPT-d method versus the FIB C method were calculated by the use of Bland-Altman plots. Results Positive biases of the FIBPT-d method versus the FIB C method with both thromboplastins were seen in NC samples (13.7% and 18.9% for HS and RP, respectively), but biases with HS in rivaroxaban and VKA patient samples were higher than that in NC samples, at 31.9% and 34.0%, respectively. LMWH patient samples showed higher bias than NC samples: 26.5% and 29.3.0% with HS and RP, respectively. UFH and dabigatran patient samples showed similar bias as NC samples. Conclusion The FIBPT-d method should not be used in anticoagulated patients, because the FIBPT-d mathematical algorithm has been validated only in normal subjects, so overestimation could occur in these patients.SUMMARYBackground The fibrinogen prothrombin time-derived (FIBPT-d) method with photo-optical coagulometers is easy and economical. However, there are few reports on the behavior of this test on samples from patients anticoagulated with direct oral anticoagulants or low molecular weight heparin (LMWH). Objective To compare fibrinogen results obtained with the Clauss (FIB C) method and the FIBPT-d method with two thromboplastins in anticoagulated patients. Population The study population comprised 295 consecutive anticoagulated patients: 99 treated with vitamin K antagonists (VKAs), 49 treated with unfractionated heparin (UFH), 47 treated with LMWH, 50 treated with rivaroxaban, 50 treated with dabigatran, and 100 normal controls (NCs). Methods Dabigatran samples were analyzed by the use of FIB C with HemosIL Fibrinogen C or 100 NHI thrombin units mL-1 reagents; rabbit brain and human recombinant thromboplastins with HemosIL PTFibrinogen HS plus (HS) and Recombiplastin 2G (RP) were used for FIBPT-d method. Heparin and rivaroxaban levels were assessed with HemosIL Liq antiXa with specific calibrators; dabigatran levels were determined with the HemosIL Direct Thrombin Inhibitor Assay. All assays were performed on the ACL TOP platform in two laboratories. Percentage biases for the FIBPT-d method versus the FIB C method were calculated by the use of Bland-Altman plots. Results Positive biases of the FIBPT-d method versus the FIB C method with both thromboplastins were seen in NC samples (13.7% and 18.9% for HS and RP, respectively), but biases with HS in rivaroxaban and VKA patient samples were higher than that in NC samples, at 31.9% and 34.0%, respectively. LMWH patient samples showed higher bias than NC samples: 26.5% and 29.3.0% with HS and RP, respectively. UFH and dabigatran patient samples showed similar bias as NC samples. Conclusion The FIBPT-d method should not be used in anticoagulated patients, because the FIBPT-d mathematical algorithm has been validated only in normal subjects, so overestimation could occur in these patients. Essentials Fibrinogen prothrombin time-derived (FIBPT-d) behavior in anticoagulated patients is under studied. FIBPT-d method overestimates fibrinogen in rivaroxaban and low molecular weight heparin samples. Unfractionated heparin and dabigatran samples showed similar bias to the control group. Rabbit brain and human recombinant thromboplastin behavior was different in rivaroxaban samples. Background The fibrinogen prothrombin time-derived (FIBPT-d) method with photo-optical coagulometers is easy and economical. However, there are few reports on the behavior of this test on samples from patients anticoagulated with direct oral anticoagulants or low molecular weight heparin (LMWH). Objective To compare fibrinogen results obtained with the Clauss (FIB C) method and the FIBPT-d method with two thromboplastins in anticoagulated patients. Population The study population comprised 295 consecutive anticoagulated patients: 99 treated with vitamin K antagonists (VKAs), 49 treated with unfractionated heparin (UFH), 47 treated with LMWH, 50 treated with rivaroxaban, 50 treated with dabigatran, and 100 normal controls (NCs). Methods Dabigatran samples were analyzed by the use of FIB C with HemosIL Fibrinogen C or 100 NHI thrombin units mL reagents; rabbit brain and human recombinant thromboplastins with HemosIL PTFibrinogen HS plus (HS) and Recombiplastin 2G (RP) were used for FIBPT-d method. Heparin and rivaroxaban levels were assessed with HemosIL Liq antiXa with specific calibrators; dabigatran levels were determined with the HemosIL Direct Thrombin Inhibitor Assay. All assays were performed on the ACL TOP platform in two laboratories. Percentage biases for the FIBPT-d method versus the FIB C method were calculated by the use of Bland-Altman plots. Results Positive biases of the FIBPT-d method versus the FIB C method with both thromboplastins were seen in NC samples (13.7% and 18.9% for HS and RP, respectively), but biases with HS in rivaroxaban and VKA patient samples were higher than that in NC samples, at 31.9% and 34.0%, respectively. LMWH patient samples showed higher bias than NC samples: 26.5% and 29.3.0% with HS and RP, respectively. UFH and dabigatran patient samples showed similar bias as NC samples. Conclusion The FIBPT-d method should not be used in anticoagulated patients, because the FIBPT-d mathematical algorithm has been validated only in normal subjects, so overestimation could occur in these patients. |
| Author | Lopez, M. Martinuzzo, M. E. Oyhamburu, J. Barrera, L. Duboscq, C. Ceresetto, J. Stemmelin, G. |
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| Cites_doi | 10.1016/j.thromres.2004.05.008 10.1055/s-0036-1579636 10.1097/00001721-199412000-00012 10.1097/00001721-199804000-00006 10.1097/00001721-200201000-00010 10.1160/TH10-10-0667 10.1016/j.thromres.2010.09.004 10.1046/j.1365-2141.2003.04256.x 10.1160/TH14-02-0161 |
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| References | 2016; 42 2008 2004; 114 2011; 106 2015; 113 1994; 5 2003; 121 2002; 13 2010; 126 1998; 9 Van Blerk (10.1111/jth.14158_bb0045) 2015; 113 De Cristofaro (10.1111/jth.14158_bb0025) 1998; 9 Mani (10.1111/jth.14158_bb0050) 2011; 106 10.1111/jth.14158_bb0055 Sobas (10.1111/jth.14158_bb0035) 2002; 13 Llamas (10.1111/jth.14158_bb0020) 2004; 114 Miesbach (10.1111/jth.14158_bb0040) 2010; 126 Mackie (10.1111/jth.14158_bb0015) 2003; 121 Undas (10.1111/jth.14158_bb0010) 2016; 42 Chitolie (10.1111/jth.14158_bb0030) 1994; 5 |
| References_xml | – volume: 126 start-page: e428 year: 2010 end-page: 33 article-title: Comparison of the fibrinogen Clauss assay and the fibrinogen PT derived method in patients with dysfibrinogenemia publication-title: Thromb Res – volume: 42 start-page: 381 year: 2016 end-page: 8 article-title: How to assess fibrinogen levels and fibrin clot properties in clinical practice? publication-title: Semin Thromb Hemost – volume: 13 start-page: 61 year: 2002 end-page: 8 article-title: Human plasma fibrinogen measurement derived from activated partial thromboplastin time clot formation publication-title: Blood Coagul Fibrinolysis – volume: 106 start-page: 156 year: 2011 end-page: 64 article-title: Rivaroxaban differentially influences ex vivo global coagulation assays based on the administration time publication-title: Thromb Haemost – volume: 121 start-page: 396 year: 2003 end-page: 404 article-title: Guidelines on fibrinogen assays publication-title: Br J Haematol – volume: 5 start-page: 955 year: 1994 end-page: 7 article-title: Inaccuracy of the ‘derived’ fibrinogen measurement publication-title: Blood Coagul Fibrinolysis – volume: 114 start-page: 73 year: 2004 end-page: 4 article-title: Diagnostic utility of comparing fibrinogen Clauss and prothrombin time derived method publication-title: Thromb Res – year: 2008 – volume: 9 start-page: 251 year: 1998 end-page: 60 article-title: Measurement of plasma fibrinogen concentration by the prothrombin‐time‐derived method publication-title: Blood Coagul Fibrinolysis – volume: 113 start-page: 154 year: 2015 end-page: 64 article-title: Influence of dabigatran and rivaroxaban on routine coagulation assays. A nationwide Belgian survey publication-title: Thromb Haemost – volume: 114 start-page: 73 year: 2004 ident: 10.1111/jth.14158_bb0020 article-title: Diagnostic utility of comparing fibrinogen Clauss and prothrombin time derived method publication-title: Thromb Res doi: 10.1016/j.thromres.2004.05.008 – volume: 42 start-page: 381 year: 2016 ident: 10.1111/jth.14158_bb0010 article-title: How to assess fibrinogen levels and fibrin clot properties in clinical practice? publication-title: Semin Thromb Hemost doi: 10.1055/s-0036-1579636 – volume: 5 start-page: 955 year: 1994 ident: 10.1111/jth.14158_bb0030 article-title: Inaccuracy of the ‘derived’ fibrinogen measurement publication-title: Blood Coagul Fibrinolysis doi: 10.1097/00001721-199412000-00012 – volume: 9 start-page: 251 year: 1998 ident: 10.1111/jth.14158_bb0025 article-title: Measurement of plasma fibrinogen concentration by the prothrombin‐time‐derived method publication-title: Blood Coagul Fibrinolysis doi: 10.1097/00001721-199804000-00006 – volume: 13 start-page: 61 year: 2002 ident: 10.1111/jth.14158_bb0035 article-title: Human plasma fibrinogen measurement derived from activated partial thromboplastin time clot formation publication-title: Blood Coagul Fibrinolysis doi: 10.1097/00001721-200201000-00010 – volume: 106 start-page: 156 year: 2011 ident: 10.1111/jth.14158_bb0050 article-title: Rivaroxaban differentially influences ex vivo global coagulation assays based on the administration time publication-title: Thromb Haemost doi: 10.1160/TH10-10-0667 – volume: 126 start-page: e428 year: 2010 ident: 10.1111/jth.14158_bb0040 article-title: Comparison of the fibrinogen Clauss assay and the fibrinogen PT derived method in patients with dysfibrinogenemia publication-title: Thromb Res doi: 10.1016/j.thromres.2010.09.004 – volume: 121 start-page: 396 year: 2003 ident: 10.1111/jth.14158_bb0015 article-title: Guidelines on fibrinogen assays publication-title: Br J Haematol doi: 10.1046/j.1365-2141.2003.04256.x – ident: 10.1111/jth.14158_bb0055 – volume: 113 start-page: 154 year: 2015 ident: 10.1111/jth.14158_bb0045 article-title: Influence of dabigatran and rivaroxaban on routine coagulation assays. A nationwide Belgian survey publication-title: Thromb Haemost doi: 10.1160/TH14-02-0161 |
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| Snippet | Essentials
Fibrinogen prothrombin time‐derived (FIBPT‐d) behavior in anticoagulated patients is under studied.
FIBPT‐d method overestimates fibrinogen in... Essentials Fibrinogen prothrombin time-derived (FIBPT-d) behavior in anticoagulated patients is under studied. FIBPT-d method overestimates fibrinogen in... BackgroundThe fibrinogen prothrombin time‐derived (FIBPT‐d) method with photo‐optical coagulometers is easy and economical. However, there are few reports on... |
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| StartPage | 1626 |
| SubjectTerms | Antagonists Anticoagulants blood coagulation tests Coagulation dabigatran Fibrinogen fibrinogen analysis Heparin low molecular weight Molecular weight Patients Population studies Prothrombin rivaroxaban Thrombin Vitamin K |
| Title | The fibrinogen prothrombin time‐derived method is not useful in patients anticoagulated with low molecular weight heparins or rivaroxaban |
| URI | https://onlinelibrary.wiley.com/doi/abs/10.1111%2Fjth.14158 https://www.ncbi.nlm.nih.gov/pubmed/29790645 https://www.proquest.com/docview/2081323909 https://www.proquest.com/docview/2043174877 |
| Volume | 16 |
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