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Prospective Study of Different Biological Tests (Multiplate, ROTEM) in a Cohort of Patients Followed for Essential Thrombocytemia (ET)

Prospective Study of Different Biological Tests (Multiplate, ROTEM) in a Cohort of Patients Followed for Essential Thrombocytemia (ET)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03212053
Acronym
THETE
Enrollment
51
Registered
2017-07-11
Start date
2017-08-11
Completion date
2019-08-08
Last updated
2019-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thrombocythemia Essential

Keywords

Essential thrombocythemia, Multiplate, ROTEM, haemorrhage, thrombosis, Vasodilatator Stimulated Phosphoprotein (VASP)

Brief summary

There is no prospective study published on the Essential Thrombocythemia and the correlation between this specific disease, its complications and the biological variations observed. The aim of this study is to demonstrate a correlation between biological tests of haemostasis, as Multiplate analyser and thromboelastometry (ROTEM) and the occurrence of clinical complications, thrombosis and/or haemorrhage, in order to determine if this biological tests could be biological prognostic factors

Interventions

BIOLOGICALbiological tests of haemostasis at each consultation (Multiplate, ROTEM, VASP)

Patients will have blood samples at each consultation (2 or 3 sampling tubes) in order to carry out systematically three biological tests

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Adult aged more than 18 years old * Patient followed in consultation for an Essential Thrombocythemia at diagnosis or during the follow-up * Collection of the informed consent * Patient affiliated to Social Security

Exclusion criteria

* Patients aged less than 18 years old * Refusal of signature of the informed consent * Patients under guardianship

Design outcomes

Primary

MeasureTime frameDescription
Occurrence of thrombotic complicationsevery 4 months, up to 18 monthsAll thrombotic complications will be gathered by the investigators during the four months following the realization of Multiplate and ROTEM test
Occurrence of haemorrhagic complicationsevery 4 months, up to 18 monthsAll haemorrhagic complications will be gathered by the investigators during the four months following the realization of Multiplate and ROTEM test

Secondary

MeasureTime frameDescription
Occurrence of thrombotic complicationsevery 4 months, up to 18 monthsAll thrombotic complications will be gathered by the investigators during the four months following the realization of VASP test
Occurrence of haemorrhagic complicationsevery 4 months, up to 18 monthsAll haemorrhagic complications will be gathered by the investigators during the four months following the realization of VASP test
Changes of tests results according to medical treatmentsevery 4 months, up to 18 monthsAll modifications of medical treatments will be gathered at each consultation to analyse changes of biological tests results
Description of platelet physiopathologythe day of inclusionUsing a specific test of release of ATP to study the platelet physiopathology in Essential Thrombocythemia only for patients seen at diagnosis and naive of all medical treatment

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026