Determination of ClotPro Paediatric Reference Range Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Determination of Reference Ranges of Thromboelastometry ClotPro Analyser in Paediatric Patients Undergoing Elective Surgery

Conditions
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Clotting and Bleeding Disorders, Child Development, Infant Development, Coagulopathy

Intervention / Treatment
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* Diagnostic Test: thromboelastometry test (TEM test)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: paediatric patients attending hospital for elective surgery or diagnostic imaging undergoing general anaesthesia are going to be eligible to participate. children whose parents agree to participate are provided with oral and written information and written informed consent has to be obtained. Exclusion Criteria: problematic blood collection age over 16 years emergency surgery systemic infection known bleeding disorders history of congenital or acquired coagulopathy including renal, liver and bone marrow disease, any medication interfering with haemostasis prophylactic or therapeutic anticoagulant therapy (acetylsalicylic acid within the last 10 days or low-molecular-weight heparins within the last 48 h) administration of colloids hydroxyethyl starch (HES)/albumin, or blood products before the blood withdrawal

Ages Eligible for Study
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Minimum Age: 1 Hour
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 0 to 3 months<br>0 (term newborns) to 3 month of age | Diagnostic Test: thromboelastometry test (TEM test)<br>* TEM test from the whole blood sample<br>|
| 4 to12 months<br>infants from 4month to 12month of age | Diagnostic Test: thromboelastometry test (TEM test)<br>* TEM test from the whole blood sample<br>|
| 13 to 24 months<br>children from 13month to 2years of age | Diagnostic Test: thromboelastometry test (TEM test)<br>* TEM test from the whole blood sample<br>|
| 2 to 5 years<br>children from 2 to 5 years of age | Diagnostic Test: thromboelastometry test (TEM test)<br>* TEM test from the whole blood sample<br>|
| 6 to 10 years<br>children from 2 to 10 years of age | Diagnostic Test: thromboelastometry test (TEM test)<br>* TEM test from the whole blood sample<br>|
| 11 to16 years<br>children from 11 to 16 years of age | Diagnostic Test: thromboelastometry test (TEM test)<br>* TEM test from the whole blood sample<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | possible differences in parameters between genders. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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thromboelastometry, viscoelastic testing, reference ranges