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The optimized CO-Rebreathing is an efficient method to evaluate the red cell mass and has been used in the vast majority of studies in sport medicine. However, this method has never been evaluated on a large scale in the diagnosis of primitive or secondary polycythemia. The standard procedure to evaluate the red cell mass is based on isotopic measurement using Cr51-labelled red cells, but its lack of availability in many centers highlights the need for a non-invasive and rapid alternative method. The purpose of this study is to evaluate and validate the CO-Rebreathing method in this set of indications.
The definition of a true polycythemia is stricto sensu an increased red cell mass (RCM) above 125% of the expected value depending on the size and the weight of the patient. However, this measurement requires an isotopic labeling of red cells and is not available in most of the hospitals. Therefore, the diagnosis of polycythemia, and particularly Polycythemia Vera (PV) is based on routine red blood cells parameters, i.e. hemoglobin level and hematocrit. If these parameters are efficient in marked polycythemia, discrepancies have been observed in milder cases. Two situations where a RCM evaluation is particularly required can be described:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CO-Rebreathing | Experimental | The intervention consists in one red cell mass determination using the CO-Rebreathing technique at diagnosis of polycythemia, in addition to the regular tests performed in this indication, including RCM isotopic measurement. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CO-Rebreathing technique at diagnosis of polycythemia | Other | The intervention consists in one red cell mass determination using the CO-Rebreathing technique at diagnosis of polycythemia, in addition to the regular tests performed in this indication, including RCM isotopic measurement. |
| Measure | Description | Time Frame |
|---|---|---|
| equivalence of RCM determination by CO-Rebreathing in comparison to the traditional isotopic measurement in the diagnosis of polycythemia | The primary outcome is to prove the equivalence of RCM determination by CO-Rebreathing in comparison to the traditional isotopic measurement in the diagnosis of polycythemia. | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| AE / SAE / EI | Incidence, grade type according to NCI-CTCAE v4.0 | 1 month |
| Cumulative incidence of thrombotic and hemorrhagic complications | Cumulative incidence of thrombotic and hemorrhagic complications List according to PT1 protocol. |
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Inclusion Criteria:
Adult patient
Informed consent obtained
Requirement of an isotopic red cell mass determination:
a - Hematocrit between 52 and 60% (men) or 48 and 56% (women) with no argument for a PV (JAK2V617F negative, EPO level normal/high).
b - Patients with a JAK2V617F positive MPN and a hematocrit level between 46 and 50% (women) or 48 and 52% for men.
No recent vascular event (<6 mois)
No unstable coronaropathy
Non smoking since 24 hours.
ECOG <2
Negativity of pregnancy test/effective contraception for childbearing age women,
Health insurance
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Loïc GARCON, professor | CHU Amiens-Picardie | Study Director |
| Lydia ROY, Doctor | CHU Henri Mondor, France | Principal Investigator |
| Marjolaine GEORGES, Doctor | Centre Hospitalier Universitaire Dijon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Amiens Picardie | Amiens | Picardie | 80054 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38044575 | Result | Maaziz N, Georges M, Basille D, Gallet M, Gardie B, Diouf M, Garcon L, Girodon F. Carbon monoxide rebreathing method is a reliable test to evaluate the red cell mass in polycythaemia. Br J Haematol. 2024 Feb;204(2):706-709. doi: 10.1111/bjh.19169. Epub 2023 Dec 3. No abstract available. |
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|
| 1 month |
| Deaths and causes | Deaths and causes | 1 month |
| Analysis of the results of VGTCO and VGTi | Analysis of the results of VGTCO and VGTi as a function of hemoglobin and hematocrit | 1 month |
| ID | Term |
|---|---|
| D011086 | Polycythemia |
| D009196 | Myeloproliferative Disorders |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D001855 | Bone Marrow Diseases |
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