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Diagnostic of Chronic Thrombocytopenia

Development of an Approach for the Differential Diagnosis of Chronic Idiopathic Thrombocytopenic Purpura and Congenital Thrombocytopenia

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04071496
Acronym
DIATROC
Enrollment
158
Registered
2019-08-28
Start date
2009-11-25
Completion date
2012-03-12
Last updated
2019-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Idiopathic Thrombocytopenic Purpura, Congenital Thrombocytopenia

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 .

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.

Interventions

OTHERBlood samples

1 dry tube of 5 ml, 3 citrated tubes of 5 ml, 1 tube citrate dextrose acid of 7 ml

Sponsors

University Hospital, Bordeaux
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
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.

Design outcomes

Primary

MeasureTime frameDescription
Modelization of congenital thrombocytopenia testAT the screeningTaking into account the clinical and biological data of patients (flow cytometry and electron microscopy), validation using resampling methods (bootstrap, jacknife, cross validation ...)
Modelization of chronic idiopathic thrombocytopenic purpura testAT the screeningTaking into account the clinical and biological data of patients (flow cytometry and electron microscopy), validation using resampling methods (bootstrap, jacknife, cross validation ...)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026