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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0 to 3 months | 0 (term newborns) to 3 month of age |
| |
| 4 to12 months | infants from 4month to 12month of age |
| |
| 13 to 24 months | children from 13month to 2years of age |
| |
| 2 to 5 years | children from 2 to 5 years of age |
| |
| 6 to 10 years | children from 2 to 10 years of age |
| |
| 11 to16 years | children from 11 to 16 years of age |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| thromboelastometry test (TEM test) | Diagnostic Test | TEM test from the whole blood sample |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Age related differences in thromboelastometry parameters | possible differences in monitored parameters across age groups; | 12 months |
| Gender-related differences in thromboelastometry parameters |
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Inclusion Criteria:
Exclusion Criteria:
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6 Individual age categories are determined to monitor: ASA physical status I-II
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| Name | Affiliation | Role |
|---|---|---|
| Katarina Laukova, MD | National Institute of Children's Diseases, Bratislava | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institute of Children's Diseases, Bratislava | Bratislava | 833 40 | Slovakia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36376099 | Derived | Laukova K, Petrikova V, Poloniova L, Babulicova L, Wsolova L, Haas T. Determination of reference ranges for the ClotPro(R) thromboelastometry device in paediatric patients. Br J Anaesth. 2023 Feb;130(2):183-190. doi: 10.1016/j.bja.2022.09.023. Epub 2022 Nov 12. |
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| ID | Term |
|---|---|
| D013927 | Thrombosis |
| D020141 | Hemostatic Disorders |
| ID | Term |
|---|---|
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006474 | Hemorrhagic Disorders |
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whole blood
Measurement of thromboelastometry parameters in paediatric patients of 6 to10 years group undergoing elective surgery or diagnostic procedure requiring general anaesthesia.
| 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. | 30 minutes post blood sampling |
possible differences in parameters between genders.
| 12 months |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |