Determination of ClotPro Paediatric Reference Range Study

January 5, 2021 updated by: Katarina Laukova, MD, National Institute of Children's Diseases, Slovakia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

322

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Slovakia
      • Bratislava, Slovakia, 833 40
        • National Institute of Children's Diseases, Bratislava

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 hour to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
0 to 3 months
0 (term newborns) to 3 month of age
Diagnostic test: thromboelastometry test (TEM test)
TEM test from the whole blood sample
4 to12 months
infants from 4month to 12month of age
Diagnostic test: thromboelastometry test (TEM test)
TEM test from the whole blood sample
13 to 24 months
children from 13month to 2years of age
Diagnostic test: thromboelastometry test (TEM test)
TEM test from the whole blood sample
2 to 5 years
children from 2 to 5 years of age
Diagnostic test: thromboelastometry test (TEM test)
TEM test from the whole blood sample
6 to 10 years
children from 2 to 10 years of age
Diagnostic test: thromboelastometry test (TEM test)
TEM test from the whole blood sample
11 to16 years
children from 11 to 16 years of age
Diagnostic test: thromboelastometry test (TEM test)
TEM test from the whole blood sample

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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 .
Time Frame: 30 minutes post blood sampling
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 .
Time Frame: 30 minutes post blood sampling
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
Time Frame: 30 minutes post blood sampling
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
Time Frame: 30 minutes post blood sampling
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
Time Frame: 30 minutes post blood sampling
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Age related differences in thromboelastometry parameters
Time Frame: 12 months
possible differences in monitored parameters across age groups;
12 months
Gender-related differences in thromboelastometry parameters
Time Frame: 12 months
possible differences in parameters between genders.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Children's Diseases, Slovakia

Investigators

  • Principal Investigator: Katarina Laukova, MD, National Institute of Children's Diseases, Bratislava

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 17, 2019

Primary Completion (Actual)

January 5, 2021

Study Completion (Actual)

January 5, 2021

Study Registration Dates

First Submitted

November 30, 2019

First Submitted That Met QC Criteria

December 4, 2019

First Posted (Actual)

December 9, 2019

Study Record Updates

Last Update Posted (Actual)

January 6, 2021

Last Update Submitted That Met QC Criteria

January 5, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NICDOS1TEMCP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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