- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03212053
Prospective Study of Different Biological Tests (Multiplate, ROTEM) in a Cohort of Patients Followed for Essential Thrombocytemia (ET) (THETE)
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Pierre Benite, France, 69495
- Centre Hospitalier Lyon Sud
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SCREENING
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: Patients with Essential Thrombocythemia
patients who come in consultation at diagnosis or during the follow-up for an Essential Thrombocythemia. They will have biological 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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Occurrence of thrombotic complications
Time Frame: every 4 months, up to 18 months
|
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
|
Occurrence of haemorrhagic complications
Time Frame: every 4 months, up to 18 months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Occurrence of thrombotic complications
Time Frame: every 4 months, up to 18 months
|
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
|
Occurrence of haemorrhagic complications
Time Frame: every 4 months, up to 18 months
|
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
|
Changes of tests results according to medical treatments
Time Frame: every 4 months, up to 18 months
|
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
|
Description of platelet physiopathology
Time Frame: the day of inclusion
|
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
|
Description of platelet physiopathology
Time Frame: the day of inclusion
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Fiorenza BARRACO, MD, Hospices Civils de Lyon
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 69HCL17_0091
- 2017-A00737-46 (OTHER: ANSM)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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