Don't get left behind! The modernized is coming. Check it out now.
Say goodbye to!
The new site is coming soon - go to the modernized
Working… Menu

French Registry of Adult Patients With Immune Thrombocytopenia and Autoimmune Hemolytic Anemia (CARMEN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02877706
Recruitment Status : Recruiting
First Posted : August 24, 2016
Last Update Posted : May 12, 2023
Information provided by (Responsible Party):
University Hospital, Toulouse

Brief Summary:
CARMEN is a national, real-world clinical registry of all adult patients with incident diagnosis of Immune thrombocytopenia (ITP) or Autoimmune Hemolytic anemia (AIHA) patients in France. It is aimed at describing ITP and AIHA clinical features, assessing the real-world risk-benefit ratio of treatments and adherence to guidelines for ITP and AIHA management.

Condition or disease Intervention/treatment
Immune Thrombocytopenia Autoimmune Hemolytic Anemia Other: no specific intervention

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 15 Years
Official Title: French Registry of Adult Patients With Immune Thrombocytopenia and Autoimmune Hemolytic Anemia
Study Start Date : June 2013
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : June 2027

Primary Outcome Measures :
  1. Incidence of Immune thrombocytopenia (ITP) and AIHA [ Time Frame: Baseline ]
    Number of new cases

  2. Natural evolution and events [ Time Frame: Baseline and follow-up ]
    Disease duration. Description of bleeding, infection, thrombosis events

Secondary Outcome Measures :
  1. Response [ Time Frame: 15 years ]
    platelet count >30 G/L and no bleeding

  2. Complete rate [ Time Frame: 15 years ]
    platelet count >30 G/L and no bleeding

  3. Treatment lines [ Time Frame: 15 years ]
    % of patients with each treatment by line of treatments

  4. Adverse drug reactions [ Time Frame: 15 years ]
    % of patients with adverse drug reaction reported by investigators

  5. Bleeding [ Time Frame: 15 years ]
    % of patients with bleeding during follow-up

  6. Rescue treatment [ Time Frame: 15 years ]
    % of patients with any treatment added during the exposure of ongoing treatment

  7. Adherence to ITP management guidelines. [ Time Frame: 15 years ]
    Percentage of patients who benefitted from the recommended examinations to detect secondary ITP and the percentage of patients who benefitted from the recommended first-line and second line treatments

  8. Events [ Time Frame: 15 years ]
    % of patients with other events of interest like cancer, death, infection, thrombosis

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Multicentric adult ITP and AIHA case recording in France, selected in centers of the French Referral Autoimmune Cytopenia Network. Both secondary and tertiary (referral) centers are participating (N=44).

Inclusion Criteria:

  • adult patients (18+ year-old)
  • newly diagnosed for ITP/AIHA or initiation of FOSFAMATINIB

Exclusion criteria:

- opposition to data collection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02877706

Layout table for location contacts
Contact: Moulis Guillaume, MD PhD
Contact: Johanne Germain, PhD

Layout table for location information
Service de Médecine Interne Recruiting
Toulouse, France, 31000
Contact: Moulis Guillaume, MD, PhD   
Sponsors and Collaborators
University Hospital, Toulouse
Layout table for investigator information
Principal Investigator: Moulis Guillaume, MD PhD University Hopsital Toulouse
Additional Information:

Layout table for additonal information
Responsible Party: University Hospital, Toulouse Identifier: NCT02877706    
Other Study ID Numbers: RC31/12/0386
First Posted: August 24, 2016    Key Record Dates
Last Update Posted: May 12, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Toulouse:
Additional relevant MeSH terms:
Layout table for MeSH terms
Purpura, Thrombocytopenic, Idiopathic
Anemia, Hemolytic
Anemia, Hemolytic, Autoimmune
Hematologic Diseases
Blood Platelet Disorders
Purpura, Thrombocytopenic
Blood Coagulation Disorders
Thrombotic Microangiopathies
Hemorrhagic Disorders
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Skin Manifestations