Blood Viscosity in Polycythemia Patients

NCT06421025 | Recruiting

• 2 other identifiers: 69HCL23_09152023-A02208-37
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Polycythemia Secondary; Polycythemia, Primary

Keywords

Polycythemia; viscosity; thromboelastometry; thrombosis

Outcome Measures

Primary Outcomes (1)

• Whole blood viscosity levels in patients with polycythemia

  The investigators expect higher blood viscosity values in polyglobulic patients with symptoms of clinical hyperviscosity than in polyglobulic patients without symptoms of clinical hyperviscosity, but no differences in hematocrit between the two polycythemia groups

  Baseline

Study Arms (1)

Patients with polycythemia

Patients with polycythemia defined as hematocrit level greater than or equal to 49% in men and 48% in women, whatever the suspected etiology. Primitive and secondary polycythemia are eligible in this observational study. Patients should not have start any cytoreductive therapy prior inclusion.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with polycythemia defined as hematocrit level greater than or equal to 49% in men and 48% in women, whatever the suspected etiology. Primitive and secondary polycythemia are eligible in this observational study. Patients should not have start any cytoreductive therapy prior inclusion.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Service d'hématologie, Hôpital Lyon Sud

Pierre-Bénite, Lyon, 69495, France

RECRUITING

Related Publications (5)

• 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. Cardiovascular events and intensity of treatment in polycythemia vera. N Engl J Med. 2013 Jan 3;368(1):22-33. doi: 10.1056/NEJMoa1208500. Epub 2012 Dec 8.

  PMID: 23216616 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Pearson TC. Hemorheology in the erythrocytoses. Mt Sinai J Med. 2001 May;68(3):182-91.

  PMID: 11373690 RESULT

MeSH Terms

Conditions

Polycythemia Vera; Polycythemia; Thrombosis

Condition Hierarchy (Ancestors)

Bone Marrow Neoplasms; Hematologic Neoplasms; Neoplasms by Site; Neoplasms; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Myeloproliferative Disorders; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Mael HEIBLIG, MD,PhD

CONTACT

478862240; mael.heiblig@chu-lyon.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2024
• First Posted: May 20, 2024
• Study Start: September 10, 2024
• Primary Completion (Estimated): September 10, 2031
• Study Completion (Estimated): September 10, 2031
• Last Updated: November 21, 2025

Record last verified: 2025-11

Locations

FR (1)