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

NCT ID: NCT02912884

Last Updated: 2020-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-09-30

Study Completion Date

2020-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Polycythemia Vera Thrombocythemia, Essential

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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PV

Patients with a diagnosis of polycythaemia vera.

No cytoreductive vs cytoreductive drugs

Intervention Type DRUG

No cytoreductive treatment vs cytoreductive drugs (hydroxycarbamide, alpha-interferon, ruxolitinib).

ET

Patients with a diagnosis of essential thrombocythaemia.

No cytoreductive vs cytoreductive drugs

Intervention Type DRUG

No cytoreductive treatment vs cytoreductive drugs (hydroxycarbamide, alpha-interferon, ruxolitinib).

Interventions

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No cytoreductive vs cytoreductive drugs

No cytoreductive treatment vs cytoreductive drugs (hydroxycarbamide, alpha-interferon, ruxolitinib).

Intervention Type DRUG

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dr Yan Beauverd

OTHER

Sponsor Role lead

Responsible Party

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Dr Yan Beauverd

Physician

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Yan Beauverd

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Geneva

Locations

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Geneva University Hospitals

Geneva, , Switzerland

Site Status

Guy's Hospital

London, , United Kingdom

Site Status

Countries

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Switzerland United Kingdom

Other Identifiers

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CCER 2016-00950

Identifier Type: -

Identifier Source: org_study_id