Thrombocythemia Essential Clinical Trial
— THETEOfficial title:
Prospective Study of Different Biological Tests (Multiplate, ROTEM) in a Cohort of Patients Followed for Essential Thrombocytemia (ET)
| Verified date | November 2019 |
| Source | Hospices Civils de Lyon |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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
| Status | Completed |
| Enrollment | 51 |
| Est. completion date | August 8, 2019 |
| Est. primary completion date | August 8, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Centre Hospitalier Lyon Sud | Pierre Benite |
| Lead Sponsor | Collaborator |
|---|---|
| Hospices Civils de Lyon |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Occurrence of thrombotic complications | All thrombotic complications will be gathered by the investigators during the four months following the realization of Multiplate and ROTEM test | every 4 months, up to 18 months | |
| Primary | Occurrence of haemorrhagic complications | All haemorrhagic complications will be gathered by the investigators during the four months following the realization of Multiplate and ROTEM test | every 4 months, up to 18 months | |
| Secondary | Occurrence of thrombotic complications | All thrombotic complications will be gathered by the investigators during the four months following the realization of VASP test | every 4 months, up to 18 months | |
| Secondary | Occurrence of haemorrhagic complications | All haemorrhagic complications will be gathered by the investigators during the four months following the realization of VASP test | every 4 months, up to 18 months | |
| Secondary | Changes of tests results according to medical treatments | All modifications of medical treatments will be gathered at each consultation to analyse changes of biological tests results | every 4 months, up to 18 months | |
| Secondary | Description of platelet physiopathology | Using 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 | the day of inclusion | |
| Secondary | Description of platelet physiopathology | Using electronic microscopy to study the platelet physiopathology in Essential Thrombocythemia only for patients seen at diagnosis and naive of all medical treatment | the day of inclusion |