DIATROC: Diagnostic of Chronic Thrombocytopenia

Sponsor
University Hospital, Bordeaux (Other)
Overall Status
Completed
CT.gov ID
NCT04071496
Collaborator
(none)
158
27.5

Study Details

Study Description

Brief Summary

The objective of this study is to provide simple and relevant clinical and biological elements to distinguish a possible Congenital Thrombocytopenia from a Chronic Idiopathic Thrombocytopenic Purpura .

Condition or Disease Intervention/Treatment Phase
  • Other: Blood samples

Detailed Description

Congenital Thrombocytopenia is a group of rare diseases, often unrecognized and misdiagnosed as Chronic Idiopathic Thrombocytopenic Purpura. These Chronic Idiopathic Thrombocytopenic Purpura, which are exclusion diagnoses, are most often treated with corticosteroids or intravenous immunoglobulins and sometimes, when thrombocytopenia is refractory, splenectomy is performed. Currently, it is often before a case of thrombocytopenia refractory to the treatment of the dysimmunity syndrome that the notion of Congenital Thrombocytopenia is evoked. The percentage of false diagnoses (misdiagnosed Chronic Idiopathic Thrombocytopenic Purpura diagnoses) seems to represent to date 10 to 20% of cases.

The objective of this study is to provide simple and relevant clinical and biological elements to distinguish a possible Congenital Thrombocytopenia from a Chronic Idiopathic Thrombocytopenic Purpura.

Study Design

Study Type:
Observational
Actual Enrollment :
158 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Development of an Approach for the Differential Diagnosis of Chronic Idiopathic Thrombocytopenic Purpura and Congenital Thrombocytopenia
Actual Study Start Date :
Nov 25, 2009
Actual Primary Completion Date :
Mar 12, 2012
Actual Study Completion Date :
Mar 12, 2012

Outcome Measures

Primary Outcome Measures

  1. Modelization of congenital thrombocytopenia test [AT the screening]

    Taking into account the clinical and biological data of patients (flow cytometry and electron microscopy), validation using resampling methods (bootstrap, jacknife, cross validation ...)

  2. Modelization of chronic idiopathic thrombocytopenic purpura test [AT the screening]

    Taking into account the clinical and biological data of patients (flow cytometry and electron microscopy), validation using resampling methods (bootstrap, jacknife, cross validation ...)

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • All patients with chronic thrombocytopenia (> 6 months) between 10 and 150 G / L, regardless of age or gender,

  • Subjects with a definite Chronic Idiopathic thrombocytopenic purpuras, - Subjects with a certain degree of certainty, sometimes pre-identified and already known at the level of the C reactive protein,

  • Subjects with chronic thrombocytopenia of undetermined origin, not definitively entering one of the 2 groups mentioned above.

Exclusion Criteria:
  • Thrombocytopenia less than 6 months old;

  • Patients with thrombocytopenia related to a viral or chronic infectious pathology (HIV infections or hepatitis C virus, bacterial infections with Helicobacter pillory, for example), an autoimmune disease, in particular systemic lupus and / or antiphospholipid syndrome, a bleeding disorder such as a Intra-vascular Disseminated coagulation, thrombotic microangiopathy, hypersplenism, a responsible medication intake, myelodysplastic syndrome, a pregnancy in progress.

  • Patients should not be treated with Immunoglobulin IV, rituximab or anti-CD20 less than 30 days before the date of collection.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University Hospital, Bordeaux

Investigators

  • Principal Investigator: Paquita NURDEN, Dr, University Hospital, Bordeaux

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT04071496
Other Study ID Numbers:
  • CHUBX 2008/06
First Posted:
Aug 28, 2019
Last Update Posted:
Aug 28, 2019
Last Verified:
Aug 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 28, 2019