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Trial record 21 of 234 for:    "Polycythemia vera"

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

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ClinicalTrials.gov Identifier: NCT02912884
Recruitment Status : Recruiting
First Posted : September 23, 2016
Last Update Posted : November 8, 2017
Sponsor:
Information provided by (Responsible Party):
Dr Yan Beauverd, University Hospital, Geneva

Brief Summary:

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.


Condition or disease Intervention/treatment
Polycythemia Vera Thrombocythemia, Essential Drug: No cytoreductive vs cytoreductive drugs

Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Treatment of Polycythaemia Vera and Essential Thrombocythaemia: Influence on the Clot Structure
Study Start Date : September 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019


Group/Cohort Intervention/treatment
PV
Patients with a diagnosis of polycythaemia vera.
Drug: No cytoreductive vs cytoreductive drugs
No cytoreductive treatment vs cytoreductive drugs (hydroxycarbamide, alpha-interferon, ruxolitinib).

ET
Patients with a diagnosis of essential thrombocythaemia.
Drug: No cytoreductive vs cytoreductive drugs
No cytoreductive treatment vs cytoreductive drugs (hydroxycarbamide, alpha-interferon, ruxolitinib).




Primary Outcome Measures :
  1. Fibrin polymerization; lag-time (in seconds) [ Time Frame: At time of inclusion ]
    Fibrin polymerization will be assessed by turbidity assay on plasma. Fibrin polymerization will be monitored at 340 nm after incubation with human thrombin and CaCl2. Results will report lag-time (seconds).

  2. Fibrin polymerization; maximal absorbance [ Time Frame: At time of inclusion ]
    Fibrin polymerization will be assessed by turbidity assay on plasma. Fibrin polymerization will be monitored at 340 nm after incubation with human thrombin and CaCl2. Results will report maximal absorbance.

  3. Clot lysis time (in minutes) [ Time Frame: At time of inclusion ]
    Fibrinolysis will be assessed by turbidity assay on plasma. Fibrinolysis will be monitored by adding tissue plasminogen activator (tPA). Results will report clot lysis time (minutes)


Secondary Outcome Measures :
  1. Clot permeation; permeation coefficient [ Time Frame: At time of inclusion ]
    Clot permeation will be reported as the calculated permeation coefficient (Ks).

  2. Quantitative parameters of thrombin generation test (TGT); endogenous thrombin potential (nM*minutes) [ Time Frame: At time of inclusion ]
    The measurement of thrombin generation is performed by the technique of calibrated automated thrombogram (CAT). Endogenous thrombin potential will be reported in nM*minutes.

  3. Quantitative parameters of thrombin generation test (TGT); peak (nM) [ Time Frame: At time of inclusion ]
    The measurement of thrombin generation is performed by the technique of calibrated automated thrombogram (CAT). Peak will be reported in nM.

  4. Quantitative parameters of thrombin generation test (TGT); time to peak (minutes) [ Time Frame: At time of inclusion ]
    The measurement of thrombin generation is performed by the technique calibrated automated thrombogram (CAT). Time to peak will be reported in minutes.

  5. Fibrin density by laser scanner confocal microscopy (number per 100 μm) [ Time Frame: At time of inclusion ]
    The fibrin density was determined by counting the number of fibres crossing an arbitrary line of 100 μm drawn through a single optical section. Each fibrin clot is prepared in duplicate and 20 density measurements were performed on each sample.


Biospecimen Retention:   Samples Without DNA
Plasma samples


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Screening for participation for MPN patients will occur at the outpatient clinic of the division of Haematology at the Geneva University Hospitals (Rue Gabrielle-Perret-Gentil 4, 1205 Geneva, Switzerland) and at the outpatient clinic of the division of Haematology at Guy's Hospitals (Great Maze Pond, London SE1 9RT, United Kingdom).
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02912884


Contacts
Contact: Yan Beauverd +41 (0)22 372 39 39 yan.beauverd@hcuge.ch

Locations
Switzerland
Geneva University Hospitals Recruiting
Geneva, Switzerland, 1205
Contact: Yan Beauverd    +41 (0)22 372 39 39    yan.beauverd@hcuge.ch   
United Kingdom
Guy's Hospital Recruiting
London, United Kingdom, SE19RT
Contact: Claire Harrison         
Sponsors and Collaborators
Dr Yan Beauverd
Investigators
Principal Investigator: Yan Beauverd University Hospital, Geneva

Responsible Party: Dr Yan Beauverd, Physician, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT02912884     History of Changes
Other Study ID Numbers: CCER 2016-00950
First Posted: September 23, 2016    Key Record Dates
Last Update Posted: November 8, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Polycythemia Vera
Polycythemia
Thrombocytosis
Thrombocythemia, Essential
Hematologic Diseases
Bone Marrow Neoplasms
Hematologic Neoplasms
Neoplasms by Site
Neoplasms
Bone Marrow Diseases
Myeloproliferative Disorders
Blood Platelet Disorders
Blood Coagulation Disorders
Hemorrhagic Disorders