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CompletedNCT03212053THETEUpdated Nov 25, 2019

Prospective Study of Different Biological Tests (Multiplate, ROTEM) in a Cohort of Patients Followed for Essential Thrombocytemia (ET)

An interventional study of biological tests of haemostasis at each consultation (Multiplate, ROTEM, VASP) in Thrombocythemia Essential, sponsored by Hospices Civils de Lyon. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-11-25.

Sponsored by Hospices Civils de Lyon · Not applicable, Interventional, and Screening

Phase
Not applicable
Study type
Interventional
Enrollment
51
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • Thrombocythemia Essential

Keywords

  • Essential thrombocythemia
  • Multiplate
  • ROTEM
  • haemorrhage
  • thrombosis
  • Vasodilatator Stimulated Phosphoprotein (VASP)
03

In context

Thrombocythemia, Essential

195 studies on the registry are indexed under Thrombocythemia, Essential; 45 are open to participants now.

This study's enrollment of 51 is close to the median of 54 across 151 interventional studies indexed under Thrombocythemia, Essential.

Browse Thrombocythemia, Essential studies →

Lead sponsor

Hospices Civils de Lyon is the lead sponsor of 1,854 studies on the registry; 441 are open to participants now.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Patients aged less than 18 years old
  • Refusal of signature of the informed consent
  • Patients under guardianship
05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
51 participants (actual)

Study arms

  • 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)

    Biological: biological tests of haemostasis at each consultation (Multiplate, ROTEM, VASP)

Interventions

  • Biologicalbiological 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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: every 4 months, up to 18 months

  2. 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

    Time frame: every 4 months, up to 18 months

Secondary outcomes

  1. Occurrence of thrombotic complications

    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

  2. Occurrence of haemorrhagic complications

    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

  3. 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

    Time frame: every 4 months, up to 18 months

  4. 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

    Time frame: the day of inclusion

  5. 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

    Time frame: the day of inclusion

07

Study locations

1 site
  • Centre Hospitalier Lyon Sud
    Pierre-Bénite, 69495, France
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Aug 2017 to primary completion in Aug 2019, 23 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 30, 2017
First posted
Jul 11, 2017
StartActual
Aug 11, 2017
Primary completionActual
Aug 8, 2019
CompletionActual
Aug 8, 2019
Last update
Nov 25, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 25, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03212053
Lead sponsor
Hospices Civils de Lyon
Responsible party
Sponsor
First posted
Jul 11, 2017
Start date
Aug 11, 2017
Primary completion
Aug 8, 2019
Completion
Aug 8, 2019
Last update
Nov 25, 2019

Study contacts

Fiorenza BARRACO, MD
principal investigator · Hospices Civils de Lyon

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.

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