Determination of ClotPro Paediatric Reference Range Study
NCT ID: NCT04190615
Last Updated: 2021-01-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
322 participants
OBSERVATIONAL
2019-12-17
2021-01-05
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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0 to 3 months
0 (term newborns) to 3 month of age
thromboelastometry test (TEM test)
TEM test from the whole blood sample
4 to12 months
infants from 4month to 12month of age
thromboelastometry test (TEM test)
TEM test from the whole blood sample
13 to 24 months
children from 13month to 2years of age
thromboelastometry test (TEM test)
TEM test from the whole blood sample
2 to 5 years
children from 2 to 5 years of age
thromboelastometry test (TEM test)
TEM test from the whole blood sample
6 to 10 years
children from 2 to 10 years of age
thromboelastometry test (TEM test)
TEM test from the whole blood sample
11 to16 years
children from 11 to 16 years of age
thromboelastometry test (TEM test)
TEM test from the whole blood sample
Interventions
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thromboelastometry test (TEM test)
TEM test from the whole blood sample
Eligibility Criteria
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Inclusion Criteria
* children whose parents agree to participate are provided with oral and written information and written informed consent has to be obtained.
Exclusion Criteria
* 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
1 Hour
16 Years
ALL
Yes
Sponsors
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National Institute of Children's Diseases, Slovakia
OTHER_GOV
Responsible Party
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Katarina Laukova, MD
Paediatric Anaesthetist, Attending physician
Principal Investigators
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Katarina Laukova, MD
Role: PRINCIPAL_INVESTIGATOR
National Institute of Children's Diseases, Bratislava
Locations
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National Institute of Children's Diseases, Bratislava
Bratislava, , Slovakia
Countries
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References
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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.
Other Identifiers
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NICDOS1TEMCP
Identifier Type: -
Identifier Source: org_study_id
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