Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06421025
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-21
First Post:
2024-05-15
Brief Title:
Blood Viscosity in Polycythemia Patients
Sponsor:
Hospices Civils de Lyon
Organization:
Hospices Civils de Lyon
Study Overview
Official Title:
Evaluation of Blood Viscosity and Hyperviscosity-related Complications Relationship in Patients With Patients With Polycythemia
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
POLYVISCO
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 Vaquezs 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 Whats 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
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 Whats 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-A02208-37 | OTHER | ID-RCB | None |