NCT04190615 is a clinical trial of thromboelastometry test (TEM test) in Clotting and Bleeding Disorders, sponsored by National Institute of Children's Diseases, Slovakia.

Who is sponsoring NCT04190615?

NCT04190615 is sponsored by National Institute of Children's Diseases, Slovakia.

What drugs are being tested in NCT04190615?

Interventions in NCT04190615: thromboelastometry test (TEM test).

What condition does NCT04190615 study?

NCT04190615 studies Clotting and Bleeding Disorders, Child Development, Infant Development, Coagulopathy.

Is NCT04190615 still recruiting?

NCT04190615 is currently completed. Last updated 6 January 2021.

Last reviewed 2021-01-06 · How we verify

NCT04190615

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Determination of ClotPro Paediatric Reference Range Study

Completed Last updated 6 January 2021

What this trial tests

trial testing thromboelastometry test (TEM test) in Clotting and Bleeding Disorders in 322 participants. Completed in 5 January 2021.

Timeline

17 December 2019

Primary endpoint
5 January 2021

5 January 2021

Quick facts

Lead sponsor	National Institute of Children's Diseases, Slovakia
Status	Completed
Study type	OBSERVATIONAL
Enrollment	322
Start date	17 December 2019
Primary completion	5 January 2021
Estimated completion	5 January 2021
Sites	1 location across Slovakia

Drugs / interventions tested

thromboelastometry test (TEM test)

Conditions studied

Clotting and Bleeding Disorders — all drugs for Clotting and Bleeding Disorders →
Child Development — all drugs for Child Development →
Infant Development — all drugs for Infant Development →
Coagulopathy — all drugs for Coagulopathy →

Sponsor

National Institute of Children's Diseases, Slovakia

Who can join

Adults 1 Hour to 16, any sex, with Clotting and Bleeding Disorders or Child Development. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Determination of reference ranges for the ClotPro® thromboelastometry device in paediatric patients.
Laukova K, Petrikova V, Poloniova L, Babulicova L, et al · · 2023 · cited 6× · PMID 36376099 · DOI 10.1016/j.bja.2022.09.023

Verify or expand the search:

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04190615 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by National Institute of Children's Diseases, Slovakia
Last refreshed: 6 January 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04190615.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing