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Completed

NCT Number: NCT04190615

Determination of ClotPro Paediatric Reference Range Study

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.

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Key information

Age range

1 hour–16 year

Sex eligibility

All sexes

Study type

Observational

Primary location

National Institute of Children's Diseases, Bratislava

Bratislava, 833 40, Slovakia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

thromboelastometry test (TEM test)

Diagnostic Test

TEM test from the whole blood sample

Primary outcomes

  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

    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.

  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 .

    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.

  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 .

    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.

  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

    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.

  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

    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.

  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

    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.

Secondary outcomes

  1. Age related differences in thromboelastometry parameters

    Time frame: 12 months

    possible differences in monitored parameters across age groups;

  2. Gender-related differences in thromboelastometry parameters

    Time frame: 12 months

    possible differences in parameters between genders.

Sponsors and collaborators

Lead sponsor

National Institute of Children's Diseases, Slovakia

Other Gov

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Dec 9, 2019
Registry last updated
Jan 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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