National Institute of Children's Diseases, Bratislava
Bratislava, 833 40, Slovakia
NCT Number: NCT04190615
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.
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Notify Me1 hour–16 year
All sexes
Observational
Bratislava, 833 40, Slovakia
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
TEM test from the whole blood sample
Time frame: 30 minutes post blood sampling
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
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
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
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
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
Measurement of thromboelastometry parameters in paediatric patients of 11-16 years group undergoing elective surgery or diagnostic procedure requiring general anaesthesia.
Time frame: 12 months
possible differences in monitored parameters across age groups;
Time frame: 12 months
possible differences in parameters between genders.
National Institute of Children's Diseases, Slovakia
Other Gov
Determination of Reference Ranges of Thromboelastometry ClotPro Analyser in Paediatric Patients Undergoing Elective Surgery
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