Back to resultsProspective Study of Different Biological Tests (Multiplate, ROTEM) in a Cohort of Patients Followed for Essential Thrombocytemia (ET) (THETE)
Primary Purpose
Thrombocythemia Essential
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
biological tests of haemostasis at each consultation (Multiplate, ROTEM, VASP)
Sponsored by
About this trial
This is an interventional screening trial for Thrombocythemia Essential focused on measuring Essential thrombocythemia, Multiplate, ROTEM, haemorrhage, thrombosis, Vasodilatator Stimulated Phosphoprotein (VASP)
Eligibility Criteria
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
Sites / Locations
- Centre Hospitalier Lyon Sud
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Patients with Essential Thrombocythemia
Arm Description
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)
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
Occurrence of thrombotic complications
All thrombotic complications will be gathered by the investigators during the four months following the realization of VASP test
Occurrence of haemorrhagic complications
All 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 treatments
All modifications of medical treatments will be gathered at each consultation to analyse changes of biological tests results
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
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
Full Information
NCT ID
NCT03212053
First Posted
June 30, 2017
Last Updated
November 22, 2019
Sponsor
Hospices Civils de Lyon
1. Study Identification
Unique Protocol Identification Number
NCT03212053
Brief Title
Prospective Study of Different Biological Tests (Multiplate, ROTEM) in a Cohort of Patients Followed for Essential Thrombocytemia (ET)
Acronym
THETE
Official Title
Prospective Study of Different Biological Tests (Multiplate, ROTEM) in a Cohort of Patients Followed for Essential Thrombocytemia (ET)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
August 11, 2017 (Actual)
Primary Completion Date
August 8, 2019 (Actual)
Study Completion Date
August 8, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thrombocythemia Essential
Keywords
Essential thrombocythemia, Multiplate, ROTEM, haemorrhage, thrombosis, Vasodilatator Stimulated Phosphoprotein (VASP)
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients with Essential Thrombocythemia
Arm Type
Other
Arm Description
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)
Intervention Type
Biological
Intervention Name(s)
biological tests of haemostasis at each consultation (Multiplate, ROTEM, VASP)
Intervention Description
Patients will have blood samples at each consultation (2 or 3 sampling tubes) in order to carry out systematically three biological tests
Primary Outcome Measure Information:
Title
Occurrence of thrombotic complications
Description
All thrombotic complications will be gathered by the investigators during the four months following the realization of Multiplate and ROTEM test
Time Frame
every 4 months, up to 18 months
Title
Occurrence of haemorrhagic complications
Description
All haemorrhagic complications will be gathered by the investigators during the four months following the realization of Multiplate and ROTEM test
Time Frame
every 4 months, up to 18 months
Secondary Outcome Measure Information:
Title
Occurrence of thrombotic complications
Description
All thrombotic complications will be gathered by the investigators during the four months following the realization of VASP test
Time Frame
every 4 months, up to 18 months
Title
Occurrence of haemorrhagic complications
Description
All haemorrhagic complications will be gathered by the investigators during the four months following the realization of VASP test
Time Frame
every 4 months, up to 18 months
Title
Changes of tests results according to medical treatments
Description
All modifications of medical treatments will be gathered at each consultation to analyse changes of biological tests results
Time Frame
every 4 months, up to 18 months
Title
Description of platelet physiopathology
Description
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
Time Frame
the day of inclusion
Title
Description of platelet physiopathology
Description
Using electronic microscopy to study the platelet physiopathology in Essential Thrombocythemia only for patients seen at diagnosis and naive of all medical treatment
Time Frame
the day of inclusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fiorenza BARRACO, MD
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Lyon Sud
City
Pierre Benite
ZIP/Postal Code
69495
Country
France
12. IPD Sharing Statement
Learn more about this trial
Prospective Study of Different Biological Tests (Multiplate, ROTEM) in a Cohort of Patients Followed for Essential Thrombocytemia (ET)
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