Trials / Completed
CompletedNCT04190615
Determination of ClotPro Paediatric Reference Range Study
Determination of Reference Ranges of Thromboelastometry ClotPro Analyser in Paediatric Patients Undergoing Elective Surgery
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 322 (actual)
- Sponsor
- National Institute of Children's Diseases, Slovakia · Other Government
- Sex
- All
- Age
- 1 Hour – 16 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | thromboelastometry test (TEM test) | TEM test from the whole blood sample |
Timeline
- Start date
- 2019-12-17
- Primary completion
- 2021-01-05
- Completion
- 2021-01-05
- First posted
- 2019-12-09
- Last updated
- 2021-01-06
Locations
1 site across 1 country: Slovakia
Source: ClinicalTrials.gov record NCT04190615. Inclusion in this directory is not an endorsement.