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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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 t

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.

Detailed Summary:

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.

Sponsor: Centre Hospitalier Universitaire, Amiens

Current 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • AE / SAE / EI [ Time Frame: 1 month ]
    Incidence, grade type according to NCI-CTCAE v4.0
  • Cumulative incidence of thrombotic and hemorrhagic complications [ Time Frame: 1 month ]
    Cumulative incidence of thrombotic and hemorrhagic complications List according to PT1 protocol.
  • Deaths and causes [ Time Frame: 1 month ]
    Deaths and causes
  • Analysis of the results of VGTCO and VGTi [ Time Frame: 1 month ]
    Analysis of the results of VGTCO and VGTi as a function of hemoglobin and hematocrit


Original Secondary Outcome: Same as current

Information By: Centre Hospitalier Universitaire, Amiens

Dates:
Date Received: December 1, 2016
Date Started: May 20, 2017
Date Completion: May 2018
Last Updated: April 25, 2017
Last Verified: April 2017