Reference ranges of thromboelastometry in healthy full-term and pre-term neonates
-
Rozeta Sokou
Abstract
Background:
Rotational thromboelastometry (ROTEM) is an attractive method for rapid evaluation of hemostasis in neonates. Currently, no reference values exist for ROTEM assays in full-term and pre-term neonates. Our aim was to establish reference ranges for standard extrinsically activated ROTEM assay (EXTEM) in arterial blood samples of healthy full-term and pre-term neonates.
Methods:
In the present study, EXTEM assay was performed in 198 full-term (≥37 weeks’ gestation) and 84 pre-term infants (<37 weeks’ gestation) using peripheral arterial whole blood samples.
Results:
Median values and reference ranges (2.5th and 97.5th percentiles) for the following main parameters of EXTEM assay were determined in full-term infants: clotting time (seconds), 41 (range, 25.9–78); clot formation time (seconds), 70 (range, 40–165.2); maximum clot firmness (mm), 66 (range, 41–84.1); lysis index at 60 min (LI60, %), 97 (range, 85–100). The only parameter with a statistically significant difference between full-term and pre-term neonates was LI60 (p=0.006). Furthermore, it was inversely correlated with gestational age (p=0.002) and birth weight (p=0.016) in pre-term neonates.
Conclusions:
In conclusion, an enhanced fibrinolytic activity in pre-term neonates was noted. For most EXTEM assay parameters, reference ranges obtained from arterial newborn blood samples were comparable with the respective values from studies using cord blood. Modified reagents, small size samples, timing of sampling, and different kind of samples might account for any discrepancies among similar studies. Reference values hereby provided can be used in future studies.
Acknowledgments
The authors would like to acknowledge their colleague, the late Leontini Foudoulaki-Paparizos, for her invaluable support and contribution to the design and conduct of this study.
Author contributions: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.
Research funding: None declared.
Employment or leadership: None declared.
Honorarium: None declared.
Competing interests: The funding organization(s) played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.
References
1. Luddington RJ. Thromboelastography/thromboelastometry. Clin Lab Haematol 2005;27:81–90.10.1111/j.1365-2257.2005.00681.xSuche in Google Scholar PubMed
2. Haizinger B, Gombotz H, Rehak P, Geiselseder G, Mair R. Activated thrombelastogram in neonates and infants with complex congenital heart disease in comparison with healthy children. Br J Anaesth 2006;97:545–52.10.1093/bja/ael206Suche in Google Scholar PubMed
3. Osthaus W, Boethig D, Johanning K, Rahe-Meyer N, Theilmeier G, Breymann T, et al. Whole blood coagulation measured by modified thrombelastography (ROTEM) is impaired in infants with congenital heart diseases. Blood Coagul Fibrinolysis 2008;19:220–5.10.1097/MBC.0b013e3282f54532Suche in Google Scholar PubMed
4. Radicioni M, Mezzetti D, Del Vecchio A, Motta M. Thromboelastography: might work in neonatology too? J Matern Fetal Neonatal Med 2012;25:18–21.10.3109/14767058.2012.714996Suche in Google Scholar PubMed
5. Strauss T, Levy-Shraga Y, Ravid B, Schushan-Eisen I, Maayan-Metzger A, Kuint J, et al. Clot formation of neonates tested by thromboelastography correlates with gestational age. Thromb Haemost 2010;103:344–50.10.1160/TH09-05-0282Suche in Google Scholar PubMed
6. Edwards RM, Naik-Mathuria BJ, Gay AN, Olutoye OO, Teruya J. Parameters of thromboelastography in healthy newborns. Am J Clin Pathol 2008;130:99–102.10.1309/LABNMY41RUD099J2Suche in Google Scholar PubMed
7. Cvirn G, Gallistl S, Kutschera J, Wagner T, Ferstl U, Jurgens G, et al. Clot strength: a comparison between cord and adult blood by means of thrombelastometry. Pediatr Hematol Oncol 2008;30:210–3.10.1097/MPH.0b013e318162bd2cSuche in Google Scholar PubMed
8. NCCLS. How to define and determine reference intervals in the clinical laboratory; approved guideline, 2nd ed. Wayne, PA: NCCLS, 2000. NCCLS document C28-A2.Suche in Google Scholar
9. R Core Team. R: A language and environment for statistical computing [Internet]. Vienna, Austria: R Foundation for Statistical Computing, 2016. Available at: http://www.R-project.org.Suche in Google Scholar
10. Sidlik R, Strauss T, Morag I, Shenkman B, Tamarin I, Lubetsky A, et al. Assessment of functional fibrinolysis in cord blood using modified thromboelastography. Pediatr Blood Cancer 2016;63:839–43.10.1002/pbc.25865Suche in Google Scholar PubMed
11. Oswald E, Stalzer B, Heitz E, Weiss M, Schmugge M, Strasak A, et al. Thromboelastometry (ROTEM) in children: age-related reference ranges and correlations with standard coagulation tests. Br J Anaesth 2010;105:827–35.10.1093/bja/aeq258Suche in Google Scholar PubMed
12. Saxonhouse MA, Manco-Johnson MJ. The evaluation and management of neonatal coagulation disorders. Semin Perinatol 2009;33:52–65.10.1053/j.semperi.2008.10.007Suche in Google Scholar PubMed
13. Parmar N, Albisetti M, Berry LR, Chan AK. The fibrinolytic system in newborns and children. Clin Lab 2006;52: 115–24.Suche in Google Scholar
14. Goldenberg NA, Hathaway WE, Jacobson L, Manco-Johnson MJ. A new global assay of coagulation and fibrinolysis. Thromb Res 2005;116:345–56.10.1016/j.thromres.2004.12.009Suche in Google Scholar PubMed
15. Pinacho A, Paramo JA. Evaluation of fibrinolytic system in full-term neonates. Int J Clin Lab Res 1995;25:149–52.10.1007/BF02592557Suche in Google Scholar PubMed
16. Reis M, Klingle J, Rauch R. In vitro fibrinolysis after adding low doses of plasminogen activators and plasmin generation with and without oxidative inactivation of plasmin inhinitors in newborns and adults. J Pediatr Hematol Oncol 1996;18:346–51.10.1097/00043426-199611000-00003Suche in Google Scholar PubMed
17. Ignjatovic V, Kenet G, Monagle P. Developmental hemostasis: recommendations for laboratories reporting pediatric samples. J Thromb Haemost 2012;10:298–300.10.1111/j.1538-7836.2011.04584.xSuche in Google Scholar PubMed
©2017 Walter de Gruyter GmbH, Berlin/Boston
Artikel in diesem Heft
- Frontmatter
- Editorials
- Reporting LDL-cholesterol levels in the era of intensive lipid management: a clarion call
- The challenges of genetic risk scores for the prediction of coronary heart disease
- Reviews
- Advanced lipoprotein testing for cardiovascular diseases risk assessment: a review of the novel approaches in lipoprotein profiling
- A review of the challenge in measuring and standardizing BCR-ABL1
- Mini Review
- Challenges in the analysis of epigenetic biomarkers in clinical samples
- Opinion Paper
- Defining a roadmap for harmonizing quality indicators in Laboratory Medicine: a consensus statement on behalf of the IFCC Working Group “Laboratory Error and Patient Safety” and EFLM Task and Finish Group “Performance specifications for the extra-analytical phases”
- Genetics and Molecular Diagnostics
- Assessment of EGFR mutation status using cell-free DNA from bronchoalveolar lavage fluid
- General Clinical Chemistry and Laboratory Medicine
- A survey of patients’ views from eight European countries of interpretive support from Specialists in Laboratory Medicine
- Verification of examination procedures in clinical laboratory for imprecision, trueness and diagnostic accuracy according to ISO 15189:2012: a pragmatic approach
- Expressing analytical performance from multi-sample evaluation in laboratory EQA
- A candidate reference method for serum potassium measurement by inductively coupled plasma mass spectrometry
- Practical motives are prominent in test-ordering in the Emergency Department
- Technical and clinical validation of the Greiner FC-Mix glycaemia tube
- Comparison of pneumatic tube system with manual transport for routine chemistry, hematology, coagulation and blood gas tests
- Accuracy of cerebrospinal fluid Aβ1-42 measurements: evaluation of pre-analytical factors using a novel Elecsys immunosassay
- Evaluation of cannabinoids concentration and stability in standardized preparations of cannabis tea and cannabis oil by ultra-high performance liquid chromatography tandem mass spectrometry
- Analytical performance and diagnostic accuracy of six different faecal calprotectin assays in inflammatory bowel disease
- Novel immunoassays for detection of CUZD1 autoantibodies in serum of patients with inflammatory bowel diseases
- Hematology and Coagulation
- Critical appraisal of discriminant formulas for distinguishing thalassemia from iron deficiency in patients with microcytic anemia
- Reference Values and Biological Variations
- Reference ranges of thromboelastometry in healthy full-term and pre-term neonates
- Cancer Diagnostics
- Immunoparesis in IgM gammopathies as a useful biomarker to predict disease progression
- Cardiovascular Diseases
- Assessment of the clinical utility of adding common single nucleotide polymorphism genetic scores to classical risk factor algorithms in coronary heart disease risk prediction in UK men
- Time and age dependent decrease of NT-proBNP after septal myectomy in hypertrophic obstructive cardiomyopathy
- Infectious Diseases
- Higher serum caspase-cleaved cytokeratin-18 levels during the first week of sepsis diagnosis in non-survivor patients
- Letters to the Editor
- Data mining for age-related TSH reference intervals in adulthood
- Intra-laboratory variation and its effect on gestational diabetes diagnosis
- Evaluation of long-term imprecision of automated complete blood cell count on the Sysmex XN-9000 system
- Sensitivity of the Sysmex XN9000 WPC-channel for detection of monoclonal B-cell populations
- Evaluation of biotin interference on immunoassays: new data for troponin I, digoxin, NT-Pro-BNP, and progesterone
- Stability of procalcitonin in cerebrospinal fluid
- Between-laboratory analysis of IgG antibodies against Aspergillus fumigatus in paired quality control samples
- Mass spectrometry vs. immunoassay in clinical and forensic toxicology: qui modus in rebus est?
- Great need for changes in higher education in Greece
- A note from the Editor in Chief regarding the Letter to the Editor “Great need for changes in higher education in Greece”
Artikel in diesem Heft
- Frontmatter
- Editorials
- Reporting LDL-cholesterol levels in the era of intensive lipid management: a clarion call
- The challenges of genetic risk scores for the prediction of coronary heart disease
- Reviews
- Advanced lipoprotein testing for cardiovascular diseases risk assessment: a review of the novel approaches in lipoprotein profiling
- A review of the challenge in measuring and standardizing BCR-ABL1
- Mini Review
- Challenges in the analysis of epigenetic biomarkers in clinical samples
- Opinion Paper
- Defining a roadmap for harmonizing quality indicators in Laboratory Medicine: a consensus statement on behalf of the IFCC Working Group “Laboratory Error and Patient Safety” and EFLM Task and Finish Group “Performance specifications for the extra-analytical phases”
- Genetics and Molecular Diagnostics
- Assessment of EGFR mutation status using cell-free DNA from bronchoalveolar lavage fluid
- General Clinical Chemistry and Laboratory Medicine
- A survey of patients’ views from eight European countries of interpretive support from Specialists in Laboratory Medicine
- Verification of examination procedures in clinical laboratory for imprecision, trueness and diagnostic accuracy according to ISO 15189:2012: a pragmatic approach
- Expressing analytical performance from multi-sample evaluation in laboratory EQA
- A candidate reference method for serum potassium measurement by inductively coupled plasma mass spectrometry
- Practical motives are prominent in test-ordering in the Emergency Department
- Technical and clinical validation of the Greiner FC-Mix glycaemia tube
- Comparison of pneumatic tube system with manual transport for routine chemistry, hematology, coagulation and blood gas tests
- Accuracy of cerebrospinal fluid Aβ1-42 measurements: evaluation of pre-analytical factors using a novel Elecsys immunosassay
- Evaluation of cannabinoids concentration and stability in standardized preparations of cannabis tea and cannabis oil by ultra-high performance liquid chromatography tandem mass spectrometry
- Analytical performance and diagnostic accuracy of six different faecal calprotectin assays in inflammatory bowel disease
- Novel immunoassays for detection of CUZD1 autoantibodies in serum of patients with inflammatory bowel diseases
- Hematology and Coagulation
- Critical appraisal of discriminant formulas for distinguishing thalassemia from iron deficiency in patients with microcytic anemia
- Reference Values and Biological Variations
- Reference ranges of thromboelastometry in healthy full-term and pre-term neonates
- Cancer Diagnostics
- Immunoparesis in IgM gammopathies as a useful biomarker to predict disease progression
- Cardiovascular Diseases
- Assessment of the clinical utility of adding common single nucleotide polymorphism genetic scores to classical risk factor algorithms in coronary heart disease risk prediction in UK men
- Time and age dependent decrease of NT-proBNP after septal myectomy in hypertrophic obstructive cardiomyopathy
- Infectious Diseases
- Higher serum caspase-cleaved cytokeratin-18 levels during the first week of sepsis diagnosis in non-survivor patients
- Letters to the Editor
- Data mining for age-related TSH reference intervals in adulthood
- Intra-laboratory variation and its effect on gestational diabetes diagnosis
- Evaluation of long-term imprecision of automated complete blood cell count on the Sysmex XN-9000 system
- Sensitivity of the Sysmex XN9000 WPC-channel for detection of monoclonal B-cell populations
- Evaluation of biotin interference on immunoassays: new data for troponin I, digoxin, NT-Pro-BNP, and progesterone
- Stability of procalcitonin in cerebrospinal fluid
- Between-laboratory analysis of IgG antibodies against Aspergillus fumigatus in paired quality control samples
- Mass spectrometry vs. immunoassay in clinical and forensic toxicology: qui modus in rebus est?
- Great need for changes in higher education in Greece
- A note from the Editor in Chief regarding the Letter to the Editor “Great need for changes in higher education in Greece”