Determination of ClotPro Paediatric Reference Range Study

Child Development Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04190615
• Other study ID #: NICDOS1TEMCP
• Status: Completed
• Start date: December 17, 2019
• Est. completion date: January 5, 2021

Study information

• Verified date: January 2021
• Source: National Institute of Children's Diseases, Slovakia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 322
• Est. completion date: January 5, 2021
• Est. primary completion date: January 5, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Child Development
• Clotting and Bleeding Disorders
• Coagulopathy
• Hemostatic Disorders
• Infant Development

Intervention

Diagnostic Test:
• thromboelastometry test (TEM test)
TEM test from the whole blood sample

Locations

Country	Name	City	State
Slovakia	National Institute of Children's Diseases, Bratislava	Bratislava

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Children's Diseases, Slovakia

Country where clinical trial is conducted

Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Age related differences in thromboelastometry parameters	possible differences in monitored parameters across age groups;	12 months
Secondary	Gender-related differences in thromboelastometry parameters	possible differences in parameters between genders.	12 months