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

Determination of ClotPro Paediatric Reference Range Study

Sponsors

Lead sponsor: National Institute of Children's Diseases, Slovakia

Source National Institute of Children's Diseases, Slovakia
Brief 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.

Detailed 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.

Overall Status Recruiting
Start Date December 17, 2019
Completion Date December 2020
Primary Completion Date December 2020
Study Type Observational
Primary Outcome
Measure 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 30 minutes post blood sampling
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 30 minutes post blood sampling
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 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 . 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 . 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 . 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 . 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 . 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 . 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 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 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 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 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 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 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 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 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 30 minutes post blood sampling
Secondary Outcome
Measure Time Frame
Age related differences in thromboelastometry parameters 12 months
Gender-related differences in thromboelastometry parameters 12 months
Enrollment 300
Condition
Intervention

Intervention type: Diagnostic Test

Intervention name: thromboelastometry test (TEM test)

Description: TEM test from the whole blood sample

Eligibility

Sampling method: Non-Probability Sample

Criteria:

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

Gender: All

Minimum age: N/A

Maximum age: 16 Years

Healthy volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Katarina Laukova, MD Principal Investigator National Institute of Childrenʼs Diseases, Bratislava
Overall Contact

Last name: Ivana Lisačkova

Phone: 00421259371333

Email: [email protected]

Location
facility status investigator
National Institute of Childrenʼs Diseases, Bratislava Recruiting Katarina Laukova, MD Principal Investigator
Location Countries

Slovakia

Verification Date

December 2019

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: National Institute of Children's Diseases, Slovakia

Investigator full name: Katarina Laukova, MD

Investigator title: Paediatric Anaesthetist, Attending physician

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Arm group label: 0 to 3 months

Description: 0 (term newborns) to 3 month of age

Arm group label: 4 to12 months

Description: infants from 4month to 12month of age

Arm group label: 13 to 24 months

Description: children from 13month to 2years of age

Arm group label: 2 to 5 years

Description: children from 2 to 5 years of age

Arm group label: 6 to 10 years

Description: children from 2 to 10 years of age

Arm group label: 11 to16 years

Description: children from 11 to 16 years of age

Patient Data Undecided
Study Design Info

Observational model: Cohort

Time perspective: Prospective

Source: ClinicalTrials.gov