An observational study in Clotting and Bleeding Disorders, Child Development and Infant Development, sponsored by National Institute of Children's Diseases, Slovakia. Completed at 1 site in Slovakia. Open to participants aged 1 Hour to 16 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-01-06.
Sponsored by National Institute of Children's Diseases, Slovakia · Observational
A new thromboelastometry analyser (ClotPro, Enicor GmbH, Munich, Germany) with improved technology was developed. This device has an improved new-generation viscoelastometric testing technique and enables the detection and assessment of factor deficiencies, low fibrinogen, platelet contribution (to whole blood coagulation), heparin and direct oral anticoagulants effects, fibrinolysis and antifibrinolytic drugs. This study aims to determine reference ranges for the ClotPro device for all paediatric age groups.
Viscoelastic testing as a relatively novel method to assess coagulation status appears favourable in reducing blood product transfusions. The tests are performed on whole blood instead of plasma, which saves time and gives a quick sight at the interaction between cellular and plasmatic clotting factors.
Reviews of the literature suggest that transfusions of packed red blood cells (pRBC), plasma, and platelets are all decreased in patients whose transfusions were guided by viscoelastic tests rather than by clinical judgement or conventional laboratory tests.
The benefits of viscoelastic coagulation monitoring have been described in many fields of surgery and intensive care. Current literature and a guideline for the treatment of massive haemorrhage in perioperative bleeding and trauma patients recommend the use of viscoelastic tests to guide haemostatic resuscitation.
503 studies on the registry are indexed under Hemostatic Disorders; 71 are open to participants now.
This study's enrollment of 322 is above the median of 100 across 229 observational studies indexed under Hemostatic Disorders.
Browse Hemostatic Disorders studies →This is the only study on the registry with National Institute of Children's Diseases, Slovakia as lead sponsor.
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6 Individual age categories are determined to monitor: ASA physical status I-II
Exclusion Criteria:
0 (term newborns) to 3 month of age
Diagnostic Test: thromboelastometry test (TEM test)
infants from 4month to 12month of age
Diagnostic Test: thromboelastometry test (TEM test)
children from 13month to 2years of age
Diagnostic Test: thromboelastometry test (TEM test)
children from 2 to 5 years of age
Diagnostic Test: thromboelastometry test (TEM test)
children from 2 to 10 years of age
Diagnostic Test: thromboelastometry test (TEM test)
children from 11 to 16 years of age
Diagnostic Test: thromboelastometry test (TEM test)
TEM test from the whole blood sample
reference range for the thromboelastometry analyser (ClotPro, Enicor GmbH, Munich, Germany) in age group 0 to 3 months for EX-test, FIB-test, IN-test, HI-test, RVV test and TPA test
Measurement of thromboelastometry parameters in paediatric patients of 0-3months age group undergoing elective surgery or diagnostic procedure requiring general anaesthesia.
Time frame: 30 minutes post blood sampling
reference range for the thromboelastometry analyser (ClotPro, Enicor GmbH, Munich, Germany) in age group 4 to 12 months for EX-test, FIB-test, IN-test, HI-test, RVV test and TPA test .
Measurement of thromboelastometry parameters in paediatric patients of 4-12months age group undergoing elective surgery or diagnostic procedure requiring general anaesthesia.
Time frame: 30 minutes post blood sampling
reference range for the thromboelastometry analyser (ClotPro, Enicor GmbH, Munich, Germany) in age group 13 to 24 months for EX-test, FIB-test, IN-test, HI-test, RVV test and TPA test .
Measurement of thromboelastometry parameters in paediatric patients of 13-24months age group undergoing elective surgery or diagnostic procedure requiring general anaesthesia.
Time frame: 30 minutes post blood sampling
reference range for the thromboelastometry analyser (ClotPro, Enicor GmbH, Munich, Germany) in age group 2 to 5 years for EX-test, FIB-test, IN-test, HI-test, RVV test and TPA test
Measurement of thromboelastometry parameters in paediatric patients of 2-5years age group undergoing elective surgery or diagnostic procedure requiring general anaesthesia.
Time frame: 30 minutes post blood sampling
reference range for the thromboelastometry analyser (ClotPro, Enicor GmbH, Munich, Germany) in age group 6 to10 years for EX-test, FIB-test, IN-test, HI-test, RVV test and TPA test
Measurement of thromboelastometry parameters in paediatric patients of 6 to10 years group undergoing elective surgery or diagnostic procedure requiring general anaesthesia.
Time frame: 30 minutes post blood sampling
reference range for the thromboelastometry analyser (ClotPro, Enicor GmbH, Munich, Germany) in age group 11-16 years for EX-test, FIB-test, IN-test, HI-test, RVV test and TPA test
Measurement of thromboelastometry parameters in paediatric patients of 11-16 years group undergoing elective surgery or diagnostic procedure requiring general anaesthesia.
Time frame: 30 minutes post blood sampling
Age related differences in thromboelastometry parameters
possible differences in monitored parameters across age groups;
Time frame: 12 months
Gender-related differences in thromboelastometry parameters
possible differences in parameters between genders.
Time frame: 12 months
Plan to share: Undecided
This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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