Clinical trial · Interventional
CO-Rebreathing in Comparison to Isotopic Red Cell Volume Determination in the Diagnosis of Primitive and Secondary Polycythemia
CO-Rebreathing in Comparison to Isotopic Red Cell Volume Determination in the Diagnosis of Primitive and Secondary Polycythemia: a Multicentric Study. Co-Rebreathing for the Measurement of Total Red Cell Mass in Polycythemia.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Polycythemia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CO-Rebreathing technique at diagnosis of polycythemia | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CO-Rebreathing
- description
- 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.
- interventionNames
- Other: CO-Rebreathing technique at diagnosis of polycythemia
Primary outcomes (1)
- measure
- equivalence of RCM determination by CO-Rebreathing in comparison to the traditional isotopic measurement in the diagnosis of polycythemia
- timeFrame
- 1 month
- description
- 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.
Secondary outcomes (4)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Adult patient 2. Informed consent obtained 3. 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. 4. No recent vascular event (\<6 mois) 5. No unstable coronaropathy 6. Non smoking since 24 hours. 7. ECOG \<2 8. Negativity of pregnancy test/effective contraception for childbearing age women, 9. Health insurance Exclusion Criteria: 1. Recent venous event \<1 months, cerebral stroke \< 6 mois) 2. Evolutive cardiopathy (\< 6 months) 3. Chronic Respiratory failure 4. Smokers with no withdrawal in the last 24 hours before CO-Rebreathing 5. Basal HbCO\>7% the day of CO-Rebreathing 6. Pregnant or breast feeding women 7. Patient enable to give an informed consent 8. Inclusion in an interventional clinical trial in the last three months. 9. Any contraindication to lung function testing
References
Publications (1)
- RESULTMaaziz 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. PMID 38044575