PolycythemiaPoly-CONCT03008642
CO-Rebreathing in Comparison to Isotopic Red Cell Volume Determination in the Diagnosis of Primitive and Secondary Polycythemia
A study testing CO-Rebreathing technique at diagnosis of polycythemia in people with Polycythemia, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Polycythemia
- What is being tested?
- CO-Rebreathing technique at diagnosis of polycythemia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2019to 1 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- No unstable coronaropathy
- Non smoking since 24 hours.
- ECOG <2
- Negativity of pregnancy test/effective contraception for childbearing age women,
- Health insurance
Who cannot join
- Recent venous event <1 months, cerebral stroke < 6 mois)
- Evolutive cardiopathy (< 6 months)
- Chronic Respiratory failure
- Smokers with no withdrawal in the last 24 hours before CO-Rebreathing
- Basal HbCO>7% the day of CO-Rebreathing
- Pregnant or breast feeding women
Show all 9Show fewer
- Patient enable to give an informed consent
- Inclusion in an interventional clinical trial in the last three months.
- Any contraindication to lung function testing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
Read the detailed description
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:
- In patients with a hematocrit level between 52 and 60% (men) or between 48 and 56% (women) in order to limit invasive investigations to patients with a confirmed polycythemia diagnosis
- In JAK2V617F positive myeloproliferative neoplasms (MPN) with hematocrit and hemoglobin levels under the PV cut-off in order to discriminate between masked PV and essential thrombocythemia CO-Rebreathing is a fast, non invasive alternative method for RCM evaluation. It is based on the high affinity of carbon monoxide (CO) for hemoglobin. The decrease in the HbCO percentage after CO inhalation is dependent on the total hemoglobin mass from which RCM can be obtained. The investigators propose a tri-centric study evaluating CO-Rebreathing as an alternative tool to measure RCM in the diagnosis of polycythemia in the two categories of patients described above.
- Conditions
- Polycythemia
- Being tested
- CO-Rebreathing technique at diagnosis of polycythemia
- Keywords
- Polycythemia, CO-Rebreathing, red cell mass determination, myeloproliferative neoplasms
- Medical subject headings
- Polycythemia, Myeloproliferative Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CO-Rebreathing technique at diagnosis of polycythemiaOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: CO-Rebreathing technique at diagnosis of polycythemia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
Secondary outcomes (4)
AE / SAE / EI
Incidence, grade type according to NCI-CTCAE v4.0
Measured: 1 month
Cumulative incidence of thrombotic and hemorrhagic complications
Cumulative incidence of thrombotic and hemorrhagic complications List according to PT1 protocol.
Measured: 1 month
Deaths and causes
Deaths and causes
Measured: 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
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2017 (estimated)
- Study start1 Apr 2019
- Primary completion1 May 2020
- Study completion1 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PolycythemiaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Loïc GARCON, professor, Study director, CHU Amiens-PicardieLydia ROY, Doctor, Principal investigator, CHU Henri Mondor, FranceMarjolaine GEORGES, Doctor, Principal investigator, Centre Hospitalier Universitaire Dijon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03008642
- Sponsor's protocol ID
- PI2016_843_0032
- Acronym
- Poly-CO
- Status last verified
- Sep 2025
- First submitted
- 1 Dec 2016
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38044575
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT03008642
- Acronym / sponsor ID
- Poly-CO / PI2016_843_0032
- Conditions
- Polycythemia
- Keywords
- Polycythemia, CO-Rebreathing, red cell mass determination, myeloproliferative neoplasms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 1 May 2020 (actual)
- First posted
- 2 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- In patients with a hematocrit level between 52 and 60% (men) or between 48 and 56% (women) in order to limit invasive investigations to patients with a confirmed polycythemia diagnosis
- In JAK2V617F positive myeloproliferative neoplasms (MPN) with hematocrit and hemoglobin levels under the PV cut-off in order to discriminate between masked PV and essential thrombocythemia CO-Rebreathing is a fast, non invasive alternative method for RCM evaluation. It is based on the high affinity of carbon monoxide (CO) for hemoglobin. The decrease in the HbCO percentage after CO inhalation is dependent on the total hemoglobin mass from which RCM can be obtained. The investigators propose a tri-centric study evaluating CO-Rebreathing as an alternative tool to measure RCM in the diagnosis of polycythemia in the two categories of patients described above.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CO-Rebreathing | Experimental | Other: CO-Rebreathing technique at diagnosis of polycythemiaThe 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (9 listed)
- Recent venous event <1 months, cerebral stroke < 6 mois)
- Evolutive cardiopathy (< 6 months)
- Chronic Respiratory failure
- Smokers with no withdrawal in the last 24 hours before CO-Rebreathing
- Basal HbCO>7% the day of CO-Rebreathing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CO-Rebreathing technique at diagnosis of polycythemiaThe 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. | Other | CO-Rebreathing |
Primary outcome
equivalence of RCM determination by CO-Rebreathing in comparison to the traditional isotopic measurement in the diagnosis of polycythemia
Time frame: 1 month
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.
4 secondary outcomes
AE / SAE / EI
Time frame: 1 month
Cumulative incidence of thrombotic and hemorrhagic complications
Time frame: 1 month
Deaths and causes
Time frame: 1 month
Analysis of the results of VGTCO and VGTi
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- Results publication: PubMed 38044575Maaziz 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Loïc GARCON, professor study director
CHU Amiens-Picardie
Lydia ROY, Doctor principal investigator
CHU Henri Mondor, France
Marjolaine GEORGES, Doctor principal investigator
Centre Hospitalier Universitaire Dijon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CO-Rebreathing technique at diagnosis of polycythemia in people with Polycythemia, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
equivalence of RCM determination by CO-Rebreathing in comparison to the traditional isotopic measurement in the diagnosis of polycythemia (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03008642, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025.