Thrombocytopenia Drug Immune Validation of New Biological Test Diagnostic (TITIM)
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|ClinicalTrials.gov Identifier: NCT02862353|
Recruitment Status : Recruiting
First Posted : August 11, 2016
Last Update Posted : July 22, 2019
The drug immune thrombocytopenia (TIM) are the most common drug cytopenias. They result from a peripheral destruction of platelets in the presence of the drug only. They usually involve immunoglobulin G (IgG) directed against either the drug molecule bound to a carrier protein or, by autoimmunity, against a hidden epitope newly exposed as a result of treatment. The most common drugs involved are quinine, some antibiotics, nonsteroidal anti-inflammatory drugs or anticonvulsants but the list is not exhaustive.
in the case of new-onset thrombocytopenia and after eliminating other possible causes, a TIM is suspected but the offending drug is difficult to identify in generally poly-medicated patients.
Several drugs may be suspected and the clinician uses biology for rapid assistance to the "de-prescription" and reduces unnecessary therapeutic substitutions in an always difficult clinical situation.
The Immunology Laboratory of the University Hospital of Saint-Etienne has developed a biological test of thrombocytopenia induction in the presence of the drug and the patient's serum that is to say its antibodies and complement fractions with cytometry reading flow. This Induction Test in vitro TIM (TITIM) is simple, fast, inexpensive, easy to transfer in hospital laboratories. But this test must be validated on well-documented clinical cases.
The purpose of this pilot project is to validate the technical and assess the clinical specificity of the test TITIM for hard imputability drugs validated by a committee of experts combining a posteriori of clinical and biological criteria of routine.
|Condition or disease||Intervention/treatment|
|Thrombocytopenia||Biological: blood sample|
|Study Type :||Observational|
|Estimated Enrollment :||20 participants|
|Official Title:||Thrombocytopenia Drug Immune Validation of New Biological Test Diagnostic|
|Actual Study Start Date :||October 25, 2017|
|Estimated Primary Completion Date :||September 2020|
|Estimated Study Completion Date :||September 2020|
|patients with thrombocytopenia drug||
Biological: blood sample
15 ml of blood
- TITIM test positivity [ Time Frame: at baseline ]TITIM test is considered positive when there is a decrease in platelet counts at least 10%.
Biospecimen Retention: Samples Without DNA
1 dry tube of 5 ml for TITIM test
1 dry tube of 7 ml for MAIPA test
1 dry tube of 5 ml for serum bank.
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 ClinicalTrials.gov identifier (NCT number): NCT02862353
|Contact: Claude LAMBERT, MD||(0)4 77 12 05 13 ext +firstname.lastname@example.org|
|Contact: Arnauld GARCIN||(0)4 77 12 02 email@example.com|
|CHU de Saint Etienne||Recruiting|
|Saint Etienne, France, 42055|
|Contact: Claude LAMBERT, MD (0)4 77 12 05 13|
|Sub-Investigator: Anne-Emmanuelle BERGER, MD|
|Sub-Investigator: Sandrine ACASSAT, MD|
|Principal Investigator: Claude LAMBERT, MD|
|Sub-Investigator: Elodie DE MAGALHAES, MD|
|Principal Investigator:||Claude LAMBERT, MD||Centre Hospitalier Universitaire de Saint Etienne|