CO-Rebreathing in Comparison to Isotopic Red Cell Volume Determination in the Diagnosis of Primitive and Secondary Polycythemia

NCT03008642 | Completed

• 1 other identifier: PI2016_843_0032
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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

Polycythemia

Keywords

Polycythemia; CO-Rebreathing; red cell mass determination; myeloproliferative neoplasms

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• AE / SAE / EI

  1 month

• Cumulative incidence of thrombotic and hemorrhagic complications

  1 month

• Deaths and causes

  1 month

• Analysis of the results of VGTCO and VGTi

  1 month

Study Arms (1)

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.

Other: CO-Rebreathing technique at diagnosis of polycythemia

Interventions

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.

CO-Rebreathing

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Patient enable to give an informed consent
• Any contraindication to lung function testing

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens Picardie

Amiens, Picardie, 80054, France

Location

Related Publications (1)

• 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.

  PMID: 38044575 RESULT

MeSH Terms

Conditions

Polycythemia; Myeloproliferative Disorders

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow Diseases

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2016
• First Posted: January 2, 2017
• Study Start: April 1, 2019
• Primary Completion: May 1, 2020
• Study Completion: May 1, 2020
• Last Updated: September 19, 2025

Record last verified: 2025-09

Locations

FR (1)