Thrombocythemia EssentialTHETENCT03212053
Prospective Study of Different Biological Tests (Multiplate, ROTEM) in a Cohort of Patients Followed for Essential Thrombocytemia (ET)
A study testing biological tests of haemostasis at each consultation (Multiplate, ROTEM, VASP) in people with Thrombocythemia Essential, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thrombocythemia Essential
- What is being tested?
- biological tests of haemostasis at each consultation (Multiplate, ROTEM, VASP)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteFrance
- Study dates
- 11 Aug 2017to 8 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients aged less than 18 years old
- Refusal of signature of the informed consent
- Patients under guardianship
Trial locations and contacts
1 site in 1 country.
About this study
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
- Conditions
- Thrombocythemia Essential
- Being tested
- biological tests of haemostasis at each consultation (Multiplate, ROTEM, VASP)
- Keywords
- Essential thrombocythemia, Multiplate, ROTEM, haemorrhage, thrombosis, Vasodilatator Stimulated Phosphoprotein (VASP)
- Medical subject headings
- Thrombocythemia, Essential, Hemorrhage, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biological tests of haemostasis at each consultation (Multiplate, ROTEM, VASP)Biological
Patients will have blood samples at each consultation (2 or 3 sampling tubes) in order to carry out systematically three biological tests
| Study group | Role | What they receive |
|---|---|---|
| Patients with Essential Thrombocythemia | Other | 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) Receives: Biological: biological tests of haemostasis at each consultation (Multiplate, ROTEM, VASP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: every 4 months, up to 18 months
Secondary outcomes (5)
Occurrence of thrombotic complications
All thrombotic complications will be gathered by the investigators during the four months following the realization of VASP test
Measured: 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 VASP test
Measured: every 4 months, up to 18 months
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
Measured: every 4 months, up to 18 months
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
Measured: the day of inclusion
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
Measured: the day of inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2017
- Study start11 Aug 2017
- Primary completion8 Aug 2019
- Study completion8 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thrombocythemia EssentialStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fiorenza BARRACO, MD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03212053
- Sponsor's protocol ID
- 69HCL17_0091
- Other IDs
- 2017-A00737-46
- Acronym
- THETE
- Status last verified
- Nov 2019
- First submitted
- 30 Jun 2017
- Last updated
- 25 Nov 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of Different Biological Tests (Multiplate, ROTEM) in a Cohort of Patients Followed for Essential Thrombocytemia (ET)
- ClinicalTrials.gov ID
- NCT03212053
- Acronym / sponsor ID
- THETE / 69HCL17_0091
- Conditions
- Thrombocythemia Essential
- Keywords
- Essential thrombocythemia, Multiplate, ROTEM, haemorrhage, thrombosis, Vasodilatator Stimulated Phosphoprotein (VASP)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 11 Aug 2017 (actual)
- Primary completion
- 8 Aug 2019 (actual)
- Study completion
- 8 Aug 2019 (actual)
- First posted
- 11 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Essential Thrombocythemia | Other | Biological: biological tests of haemostasis at each consultation (Multiplate, ROTEM, VASP)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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Patients aged less than 18 years old
- Refusal of signature of the informed consent
- Patients under guardianship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Biological | Patients with Essential Thrombocythemia |
Primary outcome
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
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
5 secondary outcomes
Occurrence of thrombotic complications
Time frame: every 4 months, up to 18 months
Occurrence of haemorrhagic complications
Time frame: every 4 months, up to 18 months
Changes of tests results according to medical treatments
Time frame: every 4 months, up to 18 months
Description of platelet physiopathology
Time frame: the day of inclusion
Description of platelet physiopathology
Time frame: the day of inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fiorenza BARRACO, MD principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing biological tests of haemostasis at each consultation (Multiplate, ROTEM, VASP) in people with Thrombocythemia Essential, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of thrombotic complications (time frame: every 4 months, up to 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2019.