Role of the Circulating Procoagulants Microparticles in the Hypercoagulability of MNP Ph1-

Myeloproliferative Neoplasm Clinical Trial

— MICROP-SMP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02862366
• Other study ID #: RC-P0004
• Status: Completed
• Start date: October 2010
• Est. completion date: January 25, 2016

Study information

• Verified date: August 2018
• Source: Lille Catholic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: January 25, 2016
• Est. primary completion date: January 25, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Myeloproliferative Disorders
• Myeloproliferative Neoplasm
• Neoplasms
• Thrombophilia

Intervention

Other:
• Blood sampling
Blood sampling every 6 month following the routine calendar of visit

Locations

Country	Name	City	State
France	CHRU Lille	Lille
France	EFS	Lille
France	GHICL	Lille

Sponsors (1)

Lead Sponsor	Collaborator
Lille Catholic University

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of the average number of microparticles detected by flow cytometry in all subgroup		Baseline