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Recruiting NCT06421025

Blood Viscosity in Polycythemia Patients

— Observational Polycythemia Secondary Polycythemia, Primary

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Polycythemia Secondary, Polycythemia, Primary. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Evaluation of Blood Viscosity and Hyperviscosity-related Complications Relationship in Patients With Patients With Polycythemia

Overview

Polycythemia (PG) corresponds to an increase in erythrocyte parameters on a blood test. A distinction is usually made between primary and secondary PG. The most common primary PG is Vaquez's disease, a hematological cancer. In Vaquez disease, an increase in hematocrit has been reported to be associated with a logarithmic increase in blood viscosity. The main complications of primary PGs (especially in Vaquez disease) are thromboembolic complications. In contrast, thromboembolic complications are rarer in secondary PG. In Vaquez disease, a hematocrit ≤ 45% has been defined as the therapeutic goal for significantly reducing thromboembolic risk. However, this has not been established for secondary PGs. All in all, the definition of the 45% threshold is based solely on clinical studies with no obvious biological argument. What's more, simply lowering blood mass through cytoreduction alone does not appear to be sufficient to significantly reduce thromboembolic risk. To investigator knowledge, there are no studies prospectively evaluating blood viscosity, its determinants and coagulation in different types of polycythemia. Nor are there any data on the direct effect on blood viscosity of the various treatments usually offered.

Primary outcome measures

  • Whole blood viscosity levels in patients with polycythemia [Time frame: Baseline]

Eligibility criteria

Inclusion criteria

  • 18 years of age or older
  • Followed for a diagnosis or suspicion of polycythemia (hematocrit greater than or equal to 49% in men and 48% in women), whatever the suspected etiology.
  • Patient affiliated to a social security scheme or similar

Exclusion criteria

  • Patient having undergone therapeutic bloodletting within 3 months prior to inclusion, or having initiated cytoreductive therapy prior to inclusion.
  • Any disease or condition other than polycythemia, chronic or not, likely to induce a change in blood viscosity (at the investigator's discretion)
  • Patient participating in another interventional research protocol that may interfere with the present protocol (at the investigator's discretion).
  • Patient under guardianship, curatorship or safeguard of justice
  • Person under psychiatric care
  • Patient under legal protection.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 1 center
  • Service d'hématologie, Hôpital Lyon Sud — Pierre-Bénite

Publications

  • Marchioli R, Finazzi G, Specchia G, Cacciola R, Cavazzina R, Cilloni D, De Stefano V, Elli E, Iurlo A, Latagliata R, Lunghi F, Lunghi M, Marfisi RM, Musto P, Masciulli A, Musolino C, Cascavilla N, Quarta G, Randi ML, Rapezzi D, Ruggeri M, Rumi E, Scortechini AR, Santini S, Scarano M, Siragusa S, Spadea A, Tieghi A, Angelucci E, Visani G, Vannucchi AM, Barbui T; CYTO-PV Collaborative Group. Cardiov PMID 23216616
  • Vogel J, Kiessling I, Heinicke K, Stallmach T, Ossent P, Vogel O, Aulmann M, Frietsch T, Schmid-Schonbein H, Kuschinsky W, Gassmann M. Transgenic mice overexpressing erythropoietin adapt to excessive erythrocytosis by regulating blood viscosity. Blood. 2003 Sep 15;102(6):2278-84. doi: 10.1182/blood-2003-01-0283. Epub 2003 May 15. PMID 12750170
  • Wade JP, du Boulay GH, Marshall J, Pearson TC, Russell RW, Shirley JA, Symon L, Wetherley-Mein G, Zilkha E. Cerebral blood flow, haematocrit and viscosity in subjects with a high oxygen affinity haemoglobin variant. Acta Neurol Scand. 1980 Apr;61(4):210-5. doi: 10.1111/j.1600-0404.1980.tb01485.x. PMID 7376820
  • Barbui T, De Stefano V, Ghirardi A, Masciulli A, Finazzi G, Vannucchi AM. Different effect of hydroxyurea and phlebotomy on prevention of arterial and venous thrombosis in Polycythemia Vera. Blood Cancer J. 2018 Nov 26;8(12):124. doi: 10.1038/s41408-018-0161-9. No abstract available. PMID 30478311
  • Pearson TC. Hemorheology in the erythrocytoses. Mt Sinai J Med. 2001 May;68(3):182-91. PMID 11373690

Identifiers

NCT: NCT06421025 · 69HCL23_0915 · 2023-A02208-37

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗