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NCT Number: NCT06421025

Blood Viscosity in Polycythemia Patients

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Service d'hématologie, Hôpital Lyon Sud

Pierre-Bénite, Lyon, 69495, France

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Whole blood viscosity levels in patients with polycythemia

    Time frame: Baseline

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Mael HEIBLIG, MD,PhD

CONTACT

[email protected]

478862240 ext. +33

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: POLYVISCO

Important dates

Study start
2024
Primary completion
2031
Study completion
2031
First posted
May 20, 2024
Registry last updated
Nov 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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