Trials Sponsors Conditions Drugs Pricing

Conditions

Child Development Clotting and Bleeding Disorders Coagulopathy Infant Development

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 .

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)

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

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

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.

Sponsors & Collaborators

National Institute of Children's Diseases, Slovakia
Governmentlead

Study Sites (1)

National Institute of Children's Diseases, Bratislava

Bratislava, 833 40, Slovakia

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

Enrollment

322 participants (actual enrollment reported by the registry).

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

Actual (reported)

Determination of ClotPro Paediatric Reference Range Study

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (6)

Study Arms (6)

0 to 3 months

4 to12 months

13 to 24 months

2 to 5 years

6 to 10 years

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

Biospecimen

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Secondary Outcomes (2)

11 to16 years

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (6)

Study Arms (6)

0 to 3 months

4 to12 months

13 to 24 months

2 to 5 years

6 to 10 years

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

Biospecimen

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Secondary Outcomes (2)

11 to16 years

You may not qualify if:

Source record

Locations