NCT04190615

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
322

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 30, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 9, 2019

Completed
8 days until next milestone

Study Start

First participant enrolled

December 17, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 5, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 5, 2021

Completed
Last Updated

January 6, 2021

Status Verified

January 1, 2021

Enrollment Period

1.1 years

First QC Date

November 30, 2019

Last Update Submit

January 5, 2021

Conditions

Clotting and Bleeding DisordersChild DevelopmentInfant DevelopmentCoagulopathy

Keywords

thromboelastometryviscoelastic testingreference ranges

Outcome Measures

Primary Outcomes (6)

  • 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 Outcomes (2)

  • Age related differences in thromboelastometry parameters

    12 months

  • Gender-related differences in thromboelastometry parameters

    12 months

Study Arms (6)

0 to 3 months

0 (term newborns) to 3 month of age

Diagnostic Test: thromboelastometry test (TEM test)

4 to12 months

infants from 4month to 12month of age

Diagnostic Test: thromboelastometry test (TEM test)

13 to 24 months

children from 13month to 2years of age

Diagnostic Test: thromboelastometry test (TEM test)

2 to 5 years

children from 2 to 5 years of age

Diagnostic Test: thromboelastometry test (TEM test)

6 to 10 years

children from 2 to 10 years of age

Diagnostic Test: thromboelastometry test (TEM test)

11 to16 years

children from 11 to 16 years of age

Diagnostic Test: thromboelastometry test (TEM test)

Interventions

thromboelastometry test (TEM test)DIAGNOSTIC_TEST

TEM test from the whole blood sample

0 to 3 months11 to16 years13 to 24 months2 to 5 years4 to12 months6 to 10 years

Eligibility Criteria

Age1 Hour - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

6 Individual age categories are determined to monitor: ASA physical status I-II 1. 0 (full term) to 3 months 2. 4 to12 months 3. 13 to 24 months 4. 2 to 5 years 5. 6 to10 years 6. 11 to 16 years Demographic data to be recorded: age, gender, weight, height.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Children's Diseases, Bratislava

Bratislava, 833 40, Slovakia

Location

Related Publications (1)

  • 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.

    PMID: 36376099DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

whole blood

MeSH Terms

Conditions

ThrombosisHemostatic Disorders

Condition Hierarchy (Ancestors)

Embolism and ThrombosisVascular DiseasesCardiovascular DiseasesHemorrhagic DisordersHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Katarina Laukova, MD

    National Institute of Children's Diseases, Bratislava

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Paediatric Anaesthetist, Attending physician

Study Record Dates

First Submitted

November 30, 2019

First Posted

December 9, 2019

Study Start

December 17, 2019

Primary Completion

January 5, 2021

Study Completion

January 5, 2021

Last Updated

January 6, 2021

Record last verified: 2021-01

Locations

SL(1)