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

Not Applicable

Completed

• Conditions: Thrombocythemia Essential
• Interventions: Biological: biological tests of haemostasis at each consultation (Multiplate, ROTEM, VASP)

• Registration Number: NCT03212053
• Lead Sponsor: Hospices Civils de Lyon

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-06-30
• Study First Submitted QC: 2017-07-06
• Study First Posted: 2017-07-11
• Study Start: 2017-08-11
• Primary Completion: 2019-08-08
• Study Completion: 2019-08-08
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-22
• Last Update Posted: 2019-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with Essential Thrombocythemia	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)

Primary Outcome Measures

Name	Time	Method
Occurrence of thrombotic complications	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	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 Outcome Measures

Name	Time	Method
Occurrence of haemorrhagic complications	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
Occurrence of thrombotic complications	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
Changes of tests results according to medical treatments	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
Description of platelet physiopathology	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

Trial Locations

Locations (1)

Centre Hospitalier Lyon Sud; 🇫🇷 Pierre Benite, France