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

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 Overview

• Status: Completed
• Conditions: Thrombocythemia Essential
• Intervention / Treatment: Biological: biological tests of haemostasis at each consultation (Multiplate, ROTEM, VASP)

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Pierre Benite, France, 69495
    • Centre Hospitalier Lyon Sud

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SCREENING
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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); Patients will have blood samples at each consultation (2 or 3 sampling tubes) in order to carry out systematically three biological tests

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of thrombotic complications	All thrombotic complications will be gathered by the investigators during the four months following the realization of VASP 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 VASP test	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	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	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	the day of inclusion

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Fiorenza BARRACO, MD, Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 11, 2017
• Primary Completion (ACTUAL): August 8, 2019
• Study Completion (ACTUAL): August 8, 2019

Study Registration Dates

• First Submitted: June 30, 2017
• First Submitted That Met QC Criteria: July 6, 2017
• First Posted (ACTUAL): July 11, 2017

Study Record Updates

• Last Update Posted (ACTUAL): November 25, 2019
• Last Update Submitted That Met QC Criteria: November 22, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: ROTEM; Multiplate; thrombosis; haemorrhage; Essential thrombocythemia; Vasodilatator Stimulated Phosphoprotein (VASP)
• Additional Relevant MeSH Terms: Bone Marrow Diseases; Hematologic Diseases; Hemorrhagic Disorders; Myeloproliferative Disorders; Blood Coagulation Disorders; Blood Platelet Disorders; Thrombocytosis; Thrombocythemia, Essential; Coagulants; Hemostatics
• Other Study ID Numbers: 69HCL17_0091; 2017-A00737-46 (OTHER: ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No