Role of the Circulating Procoagulants Microparticles in the Hypercoagulability of MNP Ph1- (MICROP-SMP)

October 30, 2018 updated by: Lille Catholic University

Role of the Circulating Procoagulants Microparticles in the Hypercoagulability of Chronic Philadelphia Negative Myeloproliferative Neoplasms

Patients with myeloproliferative neoplasms Philadelphia chromosome negative (MPNsPh1-) such as Essential thrombocytosis (ET), Polycythemia vera (PV) and Primary Myelofibrosis (PMF) have a higher risk of arterial or deep-vein thrombosis. This is responsible for a significant increase in mortality (up to 31% of increase in thrombosis risk in ET). Cellular inflation and blood hyperviscosity, resulting from these diseases, fail to account for these thromboses, as more than 50% of thrombotic complications happen under adapted antineoplastic drug treatment.

These last years, cellular microparticles (MPs) have been shown to play a major role in thrombogenesis. MPs are generated by apoptosis or the activation of malignant cells, platelets, endothelial cells or monocytes. They are fragments of plasma membrane, smaller than 1 µm, rich in phosphatidylserine, which can express the tissue factor and serve as support for the coagulation factors. Increase in the plasma concentration of procoagulant platelet microparticles has been demonstrated in other thrombotic diseases (acute coronary syndrome, disseminated intravascular coagulation DIC, etc.). The working hypothesis is that platelet microparticles are involved in the hypercoagulability of MPNs patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

128

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lille, France, 59037
        • CHRU lille
      • Lille, France, 59000
        • EFS
      • Lille, France, 59000
        • GHICL

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with ET, PV or PMF. Healthy volunteers.

Description

Inclusion Criteria for MNPs patients:

  • Age > 18
  • Establish MNPs Phi- diagnosis (ET, PV, MFP)
  • Consent to participate

Inclusion Criteria for healthy volunteers:

  • Healthy volunteers matched in age, sex with the MNPs patients, with a normal complete blood and platelet count
  • No personal thromboembolic history
  • No known thromboembolic risk factor : thrombophilia, cancers, and other disease associated with a thrombotic risk (Atrial fibrillation, etc.)
  • Not pregnant
  • Non smoker
  • For women, no hormonal contraceptives

Exclusion Criteria for MNPs patients:

  • Pregnancy
  • Patient unable to give consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Primary Myelofibrosis (PMF)
Blood sampling during routine visit
Other: Blood sampling
Blood sampling every 6 month following the routine calendar of visit
Essential thrombocytosis (ET)
Blood sampling during routine visit
Other: Blood sampling
Blood sampling every 6 month following the routine calendar of visit
Polycythemia vera (PV)
Blood sampling during routine visit
Other: Blood sampling
Blood sampling every 6 month following the routine calendar of visit

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Comparison of the average number of microparticles detected by flow cytometry in all subgroup
Time Frame: Baseline
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lille Catholic University

Investigators

  • Study Director: Agnès Charpentier, MD, PhD, GHICL

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (ACTUAL)

January 25, 2016

Study Completion (ACTUAL)

January 25, 2016

Study Registration Dates

First Submitted

August 2, 2016

First Submitted That Met QC Criteria

August 8, 2016

First Posted (ESTIMATE)

August 11, 2016

Study Record Updates

Last Update Posted (ACTUAL)

October 31, 2018

Last Update Submitted That Met QC Criteria

October 30, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC-P0004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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