Prospective Study of Different Biological Tests (Multiplate, ROTEM) in a Cohort of Patients Followed for Essential Thrombocytemia (ET)
THETE
2 other identifiers
interventional
51
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 30, 2017
CompletedFirst Posted
Study publicly available on registry
July 11, 2017
CompletedStudy Start
First participant enrolled
August 11, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 8, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 8, 2019
CompletedNovember 25, 2019
November 1, 2019
2 years
June 30, 2017
November 22, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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 Outcomes (5)
Occurrence of thrombotic complications
every 4 months, up to 18 months
Occurrence of haemorrhagic complications
every 4 months, up to 18 months
Changes of tests results according to medical treatments
every 4 months, up to 18 months
Description of platelet physiopathology
the day of inclusion
Description of platelet physiopathology
the day of inclusion
Study Arms (1)
Patients with Essential Thrombocythemia
OTHERpatients 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)
Interventions
Patients will have blood samples at each consultation (2 or 3 sampling tubes) in order to carry out systematically three biological tests
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Patients aged less than 18 years old
- Refusal of signature of the informed consent
- Patients under guardianship
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fiorenza BARRACO, MD
Hospices Civils de Lyon
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 30, 2017
First Posted
July 11, 2017
Study Start
August 11, 2017
Primary Completion
August 8, 2019
Study Completion
August 8, 2019
Last Updated
November 25, 2019
Record last verified: 2019-11