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Evaluation of a standardized protocol for thrombin generation using the calibrated automated thrombogram: A Nordic study.

https://arctichealth.org/en/permalink/ahliterature299706
Source
Haemophilia. 2019 Mar; 25(2):334-342
Publication Type
Evaluation Studies
Journal Article
Date
Mar-2019
Author
Marcus Ljungkvist
Karin Strandberg
Erik Berntorp
Roza Chaireti
Pål André Holme
Ole Halfdan Larsen
Riitta Lassila
Annukka Jouppila
Timea Szanto
Eva Zetterberg
Author Affiliation
Department of Translational Medicine & Centre for Thrombosis and Haemostasis, Lund University, Malmö, Sweden.
Source
Haemophilia. 2019 Mar; 25(2):334-342
Date
Mar-2019
Language
English
Publication Type
Evaluation Studies
Journal Article
Keywords
Automation
Blood Coagulation
Blood Coagulation Tests - methods - standards
Calibration
Humans
Laboratories - standards
Norway
Plasma - chemistry
Reference Standards
Reproducibility of Results
Thrombin - metabolism
Abstract
The thrombin generation assay-calibrated automated thrombogram (TGA-CAT) method is used to measure the overall coagulation capacity in plasma. However, the method is still considered to be a research tool, mainly because of its' lack of standardization.
Our study aimed to further raise the standardization level for the TGA-CAT method by evaluating a detailed standardization protocol and three reference plasmas' (RP)s ability to normalize results.
Six Nordic centres participated in the study, and with input from all centres a detailed laboratory standardization protocol based on the TGA-CAT manual of the manufacturer was established. Three types of plasma, hypo-,normal and hypercoagulable plasma were assessed. Three commercial lyophilized RPs were used for normalization of data. All samples were aliquoted at the Malmö centre and sent frozen at -20°C to participating centres.
Before normalization, all results under all testing conditions showed inter-laboratory coefficient of variability of 10% or lower except for endogenous thrombin potential (12%) and peak (14%) in hypo-plasma with 1 pmol/L tissue factor as starting agent. Successful normalization, improving variability in results, was obtained with two of the three evaluated RPs (HemosIL RP and Affinity RP).
With our standardization concept, we were able to produce TGA-CAT results as robust as standard coagulation assays used in the routine laboratories. Normalization with HemosIL RP may be considered in populations with low or unknown coagulability, while when analysing plasma samples from populations where hypercoagulability is known or suspected, normalization with Affinity RP may be preferred.
PubMed ID
30715788 View in PubMed
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[Evaluation of equilibrium between coagulating and fibrinolytic blood systems in practically healthy people in various physiologic states using the original express-micromethod]

https://arctichealth.org/en/permalink/ahliterature59551
Source
Fiziol Zh. 1993 Jan-Feb;39(1):24-8
Publication Type
Article
Author
T I Lezhen
Ie M Makogonenko
O O Sushko
L I Sokolovska
A Ia Senchuk
Source
Fiziol Zh. 1993 Jan-Feb;39(1):24-8
Language
Ukrainian
Publication Type
Article
Keywords
Adult
Aged
Aged, 80 and over
Aging - blood
Blood Coagulation - physiology
Blood Coagulation Tests - methods
English Abstract
Female
Fibrinolysis - physiology
Humans
Infant, Newborn
Male
Middle Aged
Nephelometry and Turbidimetry
Pregnancy - blood
Abstract
A new turbodimetric proximate-micromethod has been used to determine six indices of blood coagulation and fibrinolysis (coagulation time, coagulation rate, maximal absorption, fibrinolysis rate, time of fibrin semilysis and complete lysis) in young donors, newborns, healthy pregnant women, healthy elderly and old age people. A positive correlation of the results obtained using the method suggested by the authors and conventional methods is found for the indices of blood coagulation and fibrinolysis. It is revealed that the above indices change depending on the physiological state of the human organism.
PubMed ID
8335121 View in PubMed
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Factor VII assay performance: an analysis of the North American Specialized Coagulation Laboratory Association proficiency testing results.

https://arctichealth.org/en/permalink/ahliterature114694
Source
Int J Lab Hematol. 2013 Jun;35(3):314-21
Publication Type
Article
Date
Jun-2013
Author
N D Zantek
P. Hsu
M A Refaai
M. Ledford-Kraemer
P. Meijer
E M Van Cott
Author Affiliation
Department of Laboratory Medicine and Pathology, University of Minnesota, Minneapolis, MN, USA.
Source
Int J Lab Hematol. 2013 Jun;35(3):314-21
Date
Jun-2013
Language
English
Publication Type
Article
Keywords
Animals
Blood Coagulation Tests - methods - standards - statistics & numerical data
Calibration
Canada
Factor VII - analysis - standards
Factor VII Deficiency - blood - diagnosis
Humans
Laboratories - standards - statistics & numerical data
Laboratory Proficiency Testing - methods - standards - statistics & numerical data
Rabbits
Reference Values
Reproducibility of Results
Sensitivity and specificity
Thromboplastin - standards
United States
Abstract
The performance of factor VII (FVII) assays currently used by clinical laboratories was examined in North American Specialized Coagulation Laboratory Association (NASCOLA) proficiency tests. Data from 12 surveys conducted between 2008 and 2010, involving 20 unique specimens plus four repeat-tested specimens, were analyzed. The number of laboratories per survey was 49-54 with a total of 1224 responses. Numerous reagent/instrument combinations were used. For FVII > 80 or 50 U/dL, among commonly used methods, one thromboplastin and one calibrator produced results 5-6 U/dL higher and another thromboplastin and calibrator produced results 5-6 U/dL lower than all other methods, and human thromboplastin differed from rabbit by +7.6 U/dL. Preliminary evidence suggests these differences could be due to the calibrator. For FVII
PubMed ID
23590660 View in PubMed
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Interlaboratory variation in heparin monitoring: Lessons from the Quality Management Program of Ontario coagulation surveys.

https://arctichealth.org/en/permalink/ahliterature141872
Source
Thromb Haemost. 2010 Oct;104(4):837-44
Publication Type
Article
Date
Oct-2010
Author
Adam Cuker
Anne Raby
Karen A Moffat
Greg Flynn
Mark A Crowther
Author Affiliation
University of Pennsylvania, Philadelphia, Pennsylvania, USA. adam.cuker@uphs.upenn.edu
Source
Thromb Haemost. 2010 Oct;104(4):837-44
Date
Oct-2010
Language
English
Publication Type
Article
Keywords
Blood Coagulation Tests - methods
Factor Xa - metabolism
Health Care Surveys
Heparin - blood
Humans
International Normalized Ratio
Laboratories, Hospital - statistics & numerical data
Observer Variation
Ontario
Quality Assurance, Health Care
Reproducibility of Results
Sensitivity and specificity
Abstract
Unfractionated heparin (UFH) monitoring is subject to substantial interlaboratory variation. We analysed results of annual coagulation surveys administered by the Quality Management Program - Laboratory Services (Toronto, ON, Canada) from 2003 to 2007 to evaluate variation in UFH monitoring across Ontario. Participating laboratories performed an activated partial thromboplastin time (APTT) utilising their local methodology on lyophilised human plasma spiked with UFH. In the 2006 and 2007 surveys, laboratories licensed to perform anti-Xa assays also reported anti-Xa activity results. The APTT differed significantly between heparin-sensitive and heparin-insensitive methods (p
PubMed ID
20664895 View in PubMed
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[Laboratory assessment of haemostatic parameters in patients taking a direct thrombin inhibitor].

https://arctichealth.org/en/permalink/ahliterature260755
Source
Angiol Sosud Khir. 2014;20(4):37-41
Publication Type
Article
Date
2014
Author
O O Beliavskaia
T V Vavilova
Source
Angiol Sosud Khir. 2014;20(4):37-41
Date
2014
Language
Russian
Publication Type
Article
Keywords
Aged
Antithrombins - administration & dosage - adverse effects
Atrial Fibrillation - blood - complications - drug therapy
Benzimidazoles - administration & dosage - adverse effects
Blood Coagulation - drug effects
Blood Coagulation Tests - methods
Dose-Response Relationship, Drug
Drug Monitoring - methods
Female
Follow-Up Studies
Hemorrhage - chemically induced - prevention & control
Humans
Male
Prothrombin - analysis - metabolism
Reproducibility of Results
Risk assessment
Russia
Stroke - etiology - prevention & control
Thromboembolism - etiology - prevention & control
Treatment Outcome
beta-Alanine - administration & dosage - adverse effects - analogs & derivatives
Abstract
The problem of prevention and treatment of thromboembolic complications has a significant place in clinical practice for many years. The gold-standard agents in long-term protection from embologenic strokes, secondary prevention of venous thromboses and embolisms still remain vitamin K antagonists (in Russia - warfarin). However, despite high efficacy, administration of warfarin is fraught with dangers and associated with a series of inconveniences. A direct thrombin inhibitor, dabigatran etexilate (hereinafter referred to as dabigatran) was approved in the Russian Federation for prevention of thromboembolic complications in orthopaedic practice (2009), for prevention of ischaemic embologenic stroke in atrial fibrillation (2011) and for treatment of recurrent thrombosis of deep veins and pulmonary artery thromboembolism (2014). A characteristic feature of a therapeutic agent possessing an anticoagulation effect is correlation between intensity of hypocoagulation and haemorrhage. The effect of dabigatran on the laboratory parameters of haemostasis has been studied insufficiently, with no practical guidelines on assessing these alterations for prediction of the risk for haemorrhagic and thromboembolic complications. The present study included a total of 65 patients with non-valvular aetiology atrial fibrillation, taking dabigatran during from 6 to 18 months. All patients underwent laboratory assessment of the coagulation level and measuring blood coagulation activation markers in dynamics 10-14 days, 1, 6, 12 and 18 months after taking the agent. Thromboembolic and haemorrhagic risks were also assessed. It was revealed that administration of dabigatran leads to alterations in the main parameters of coagulogram. Determination of prothrombin (in % according to Quick's method) and activated partial thromboplastin time may be used for qualitative assessment of hypocoagulation. During the follow up period no statistically significant changes in the coagulation activation markers level were observed.
PubMed ID
25490355 View in PubMed
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[Peculiarities of thrombin generation and prognosis of unfavourable outcome in patients with severe pneumonia and pneumogenic sepsis].

https://arctichealth.org/en/permalink/ahliterature262233
Source
Klin Med (Mosk). 2014;92(6):41-6
Publication Type
Article
Date
2014
Author
T I Martynenko
A P Momot
I V Balatskaia
Ia N Shoikhet
A A Grebeniuk
O V Rusakova
S Iu Kapitulin
Source
Klin Med (Mosk). 2014;92(6):41-6
Date
2014
Language
Russian
Publication Type
Article
Keywords
Blood Coagulation Tests - methods - standards
Cohort Studies
Female
Humans
Male
Middle Aged
Monitoring, Physiologic - methods
Outcome Assessment (Health Care)
Pneumonia, Bacterial - complications - metabolism - mortality - physiopathology
Predictive value of tests
Prognosis
Russia - epidemiology
Sepsis - etiology - physiopathology
Severity of Illness Index
Thrombin - analysis - metabolism
Time Factors
Abstract
The study of thrombin production included 68 patients with severe pneumonia (SP) undergoing monitoring plasma thrombin potential in the thrombin generation test. Thrombin production was found to decrease in the patients who died compared with those alive on days 3-5 and 7-10 after onset of the disease. Endogenous thrombin potential decreased progressively during the first 7-10 days among the patients with the fatal outcome of SP. This trend in thrombin generation can be used to predict the unfavourable outcome of SP.
PubMed ID
25799829 View in PubMed
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Regional quality control of coagulation assay procedures (normotest, simplastin-a and thrombotest).

https://arctichealth.org/en/permalink/ahliterature253147
Source
Thromb Diath Haemorrh. 1974 Sep 30;32(1):79-89
Publication Type
Article
Date
Sep-30-1974
Author
J. Kahan
Source
Thromb Diath Haemorrh. 1974 Sep 30;32(1):79-89
Date
Sep-30-1974
Language
English
Publication Type
Article
Keywords
Analysis of Variance
Blood Coagulation Tests - methods - standards
Factor V - analysis
Factor VII - analysis
Factor X - analysis
Fibrinogen - analysis
Humans
Prothrombin - analysis
Quality Control
Statistics as Topic
Sweden
Thromboplastin - standards
Abstract
The report is based on the first 8 months' operation of an extended regional quality control program involving 20 hospital laboratories in the Stockholm area. The test material was commercially available lyophilized human reference plasma containing uniformly reduced levels of factors II, VII and X, and optimal concentrations of fibrinogen and factor V. Each participant received 2 batches of the test material with different activity at each 4-week period. Participants were requested to analyze the specimens, independently and in duplicates, along with ordinary patient samples three times weekly during each period. The levels of the factors in the batches were changed in each period. The total number of reported results was 3113. The statistical analysis of values included the calculation of means and variances within and between different thromboplastins (Normotest, Simplastin-A, Thrombotest), different techniques (venous and capillary blood, automatic and manual end-point determination), and laboratories classified according to the category and number of personnel and of performed coagulation tests. Systematic differences between thromboplastins, techniques and laboratories, even using the same type of thromboplastin, contributed a significantly greater amount than within-laboratory random variation to the total variation of determinations. The obtained results indicate the urgency of the quality control of coagulation activity tests.
PubMed ID
4454048 View in PubMed
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[The blood coagulation aspects of acute infectious myocarditis]

https://arctichealth.org/en/permalink/ahliterature54375
Source
Lik Sprava. 1998 Mar-Apr;(2):40-3
Publication Type
Article
Author
B H Doroshenko
Source
Lik Sprava. 1998 Mar-Apr;(2):40-3
Language
Ukrainian
Publication Type
Article
Keywords
Acute Disease
Adult
Blood Coagulation - drug effects
Blood Coagulation Tests - methods
Drug Therapy, Combination
English Abstract
Humans
Infection - blood - drug therapy
Myocarditis - blood - drug therapy
Abstract
Overall thirty-four patients with infectious myocarditis were studied by 9 coagulation techniques. A major proportion of this patient population displayed stage I blood disseminated intravascular coagulation syndrome. Treatment with coagulants, antiaggregants or nonsteroid antiinflammatory drugs resulted in positive dynamics of indices for coagulative and thrombovascular hemostasis, which observation significantly correlated with clinical improvement.
PubMed ID
9670651 View in PubMed
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9 records – page 1 of 1.