Trials / Completed
CompletedNCT02862353
Thrombocytopenia Drug Immune Validation of New Biological Test Diagnostic
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 8 (actual)
- Sponsor
- Centre Hospitalier Universitaire de Saint Etienne · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | blood sample | 15 ml of blood |
Timeline
- Start date
- 2017-10-25
- Primary completion
- 2021-03-15
- Completion
- 2021-03-15
- First posted
- 2016-08-11
- Last updated
- 2024-01-17
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT02862353. Inclusion in this directory is not an endorsement.