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Determination of ClotPro Paediatric Reference Range Study

NCT04190615 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 322

Last updated 2021-01-06

No results posted yet for this study

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.

Conditions

  • Clotting and Bleeding Disorders
  • Child Development
  • Infant Development
  • Coagulopathy

Interventions

DIAGNOSTIC_TEST

thromboelastometry test (TEM test)

TEM test from the whole blood sample

Sponsors & Collaborators

  • National Institute of Children's Diseases, Slovakia

    lead OTHER_GOV

Principal Investigators

  • Katarina Laukova, MD · National Institute of Children's Diseases, Bratislava

Eligibility

Min Age
1 Hour
Max Age
16 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-12-17
Primary Completion
2021-01-05
Completion
2021-01-05

Countries

  • Slovakia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04190615 on ClinicalTrials.gov