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Completed

NCT Number: NCT03212053

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

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

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Key information

Conditions

Thrombocythemia Essential Blood Coagulation Disorders Blood Platelet Disorders Bone Marrow Diseases Cardiovascular Diseases Embolism and Thrombosis Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhage Hemorrhagic Disorders Myeloproliferative Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Thrombocythemia, Essential Thrombocytosis Thrombosis Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Lyon Sud

Pierre-Bénite, 69495, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: THETE

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jul 11, 2017
Registry last updated
Nov 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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