Treatment of Polycythaemia Vera and Essential Thrombocythaemia: Influence on the Clot Structure (MPNClot)

Dr Yan Beauverd

Status

Completed

Conditions

Polycythemia Vera

Thrombocythemia, Essential

Treatments

Drug: No cytoreductive vs cytoreductive drugs

Study type

Observational

Funder types

Other

Identifiers

NCT02912884

CCER 2016-00950

Details and patient eligibility

About

Myeloproliferative neoplasms (MPN) such as Polycythemia Vera (PV) and, Essential Thrombocythaemia (ET) are rare clonal myeloid neoplasms associated with an increased risk of both venous and arterial thrombosis. Thrombotic complications are the main determinant of morbidity and in a less extend mortality.

Routine haemostasis analysis (TP, aPTT) are usually normal and are useless to demonstrate a hypercoagulable state. However, previous evidence suggests that global coagulation tests such as thrombin generation or thromboelastometry are able to detect signs of procoagulant imbalance in MPN. Similarly, current data seems to demonstrate that fibrin clot properties (clot permeability, turbidimetry, clot lysis time) properties is altered suggesting an hypercoagulable state.

Goals of PV and ET treatments are to control blood count to reduce the risk of thrombotic events. Moreover, new drugs such as Janus Kinase Inhibitors (JAKi) were recently licensed for PV and are under investigations on clinical trial for ET. It is currently unknown if treatments that were used for ET and PV, and especially JAKi are able to modify the hypercoagulable state that is observed in those diseases, and if there is difference between drugs.

To evaluate impact of MPN treatment on prothrombotic haemostatic profile, we propose to evaluate global coagulation and fibrin clot properties in MPN, depending on the treatment.

Enrollment

80 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

All men and women, older than 18 years, with a diagnosis of PV or ET (primary or secondary) according to the 2008 World Health Organization (WHO) classification.

Exclusion criteria

Lack of participant's consent;
Concomitant treatment with anticoagulant drugs (anti-vitamin K, heparin or direct oral anticoagulant drugs);
Active cancer other than non-melanoma skin cancer (defined as cancer diagnosis <5 years or treatment <2 years);
Recent infection (<30d);
Recent surgery (<30d);
Recent hospitalization (<30d);
Recent thromboembolic or cardiovascular event (<3m).