Diagnostic of Chronic Thrombocytopenia

Chronic Idiopathic Thrombocytopenic Purpura Clinical Trial

— DIATROC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04071496
• Other study ID #: CHUBX 2008/06
• Status: Completed
• Start date: November 25, 2009
• Est. completion date: March 12, 2012

Study information

• Verified date: August 2019
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 158
• Est. completion date: March 12, 2012
• Est. primary completion date: March 12, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Idiopathic Thrombocytopenic Purpura
• Congenital Thrombocytopenia
• Purpura
• Purpura, Thrombocytopenic
• Purpura, Thrombocytopenic, Idiopathic
• Thrombocytopenia

Intervention

Other:
• Blood samples
1 dry tube of 5 ml, 3 citrated tubes of 5 ml, 1 tube citrate dextrose acid of 7 ml

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modelization of congenital thrombocytopenia test	Taking into account the clinical and biological data of patients (flow cytometry and electron microscopy), validation using resampling methods (bootstrap, jacknife, cross validation ...)	AT the screening
Primary	Modelization of chronic idiopathic thrombocytopenic purpura test	Taking into account the clinical and biological data of patients (flow cytometry and electron microscopy), validation using resampling methods (bootstrap, jacknife, cross validation ...)	AT the screening