Clinical trial NCT04190615: Determination of ClotPro Paediatric Reference Range Study
Official title: Determination of Reference Ranges of Thromboelastometry ClotPro Analyser in Paediatric Patients Undergoing Elective Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Clotting and Bleeding Disorders
Child Development
Infant Development
Coagulopathy
Keywords: thromboelastometry
viscoelastic testing
reference ranges
Lead sponsor: National Institute of Children's Diseases, Slovakia
Sponsor class: OTHER_GOV
First posted: 2019-12-09
Enrollment: 322
Sex: ALL
Minimum age (years): 1
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
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
timeFrame: 30 minutes post blood sampling
measure: 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 .
timeFrame: 30 minutes post blood sampling
measure: 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 .
timeFrame: 30 minutes post blood sampling
measure: 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
timeFrame: 30 minutes post blood sampling
measure: 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
timeFrame: 30 minutes post blood sampling
measure: 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
timeFrame: 30 minutes post blood sampling
Secondary outcomes:
measure: Age related differences in thromboelastometry parameters
timeFrame: 12 months
measure: Gender-related differences in thromboelastometry parameters
timeFrame: 12 months
Other outcomes:
Locations:
city: Bratislava
country: Slovakia
facility: National Institute of Children's Diseases, Bratislava
Study officials:
affiliation: National Institute of Children's Diseases, Bratislava
name: Katarina Laukova, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.