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Clotting and Bleeding DisordersNCT04190615

Determination of ClotPro Paediatric Reference Range Study

An observational study of Clotting and Bleeding Disorders and Child Development, run by National Institute of Children's Diseases, Slovakia at 1 site in Slovakia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 1 hour to 16 yearsHealthy volunteers can take part
What is being tested?
thromboelastometry test (TEM test)
How many people
322 participants
Where
1 siteSlovakia
Study dates
17 Dec 2019to 5 Jan 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 hour to 16 years
  • All sexes
  • Healthy volunteers accepted
  • Child

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.

Who may be able to join

  • 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.

Who cannot join

  • 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,
Show all 9Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Slovakia1 site

  • National Institute of Children's Diseases, Bratislava

    Bratislava, 833 40

Other trials in Slovakia

About this study

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

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.

Read the 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.

Being tested
thromboelastometry test (TEM test)
Keywords
thromboelastometry, viscoelastic testing, reference ranges
Medical subject headings
Thrombosis, Hemostatic Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • thromboelastometry test (TEM test)Diagnostic test

    TEM test from the whole blood sample

Study groups in NCT04190615
Study groupRoleWhat they receive
0 to 3 months0 (term newborns) to 3 month of age
Receives: Diagnostic Test: thromboelastometry test (TEM test)
4 to12 monthsinfants from 4month to 12month of age
Receives: Diagnostic Test: thromboelastometry test (TEM test)
13 to 24 monthschildren from 13month to 2years of age
Receives: Diagnostic Test: thromboelastometry test (TEM test)
2 to 5 yearschildren from 2 to 5 years of age
Receives: Diagnostic Test: thromboelastometry test (TEM test)
6 to 10 yearschildren from 2 to 10 years of age
Receives: Diagnostic Test: thromboelastometry test (TEM test)
11 to16 yearschildren from 11 to 16 years of age
Receives: Diagnostic Test: thromboelastometry test (TEM test)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 30 minutes post blood sampling

  2. 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.

    Measured: 30 minutes post blood sampling

  3. 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.

    Measured: 30 minutes post blood sampling

  4. 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.

    Measured: 30 minutes post blood sampling

  5. 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.

    Measured: 30 minutes post blood sampling

  6. 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.

    Measured: 30 minutes post blood sampling

Secondary outcomes (2)

  1. Age related differences in thromboelastometry parameters

    possible differences in monitored parameters across age groups;

    Measured: 12 months

  2. Gender-related differences in thromboelastometry parameters

    possible differences in parameters between genders.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2019
  2. Study start17 Dec 2019
  3. Primary completion5 Jan 2021
  4. Study completion5 Jan 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
322 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04190615
Sponsor's protocol ID
NICDOS1TEMCP
Status last verified
Jan 2021
First submitted
30 Nov 2019
Last updated
6 Jan 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 36376099

Questions about this trial

What is this clinical trial studying?

An observational study of Clotting and Bleeding Disorders and Child Development, run by National Institute of Children's Diseases, Slovakia at 1 site in Slovakia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Slovakia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: 30 minutes post blood sampling). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04190615, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2021.

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