Thrombocytopenia Drug Immune Validation of New Biological Test Diagnostic

Thrombocytopenia Clinical Trial

— TITIM  

Official title:

Thrombocytopenia Drug Immune Validation of New Biological Test Diagnostic

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02862353
• Other study ID #: 1608040
• Secondary ID: 2016-A00858-43
• Status: Completed
• Start date: October 25, 2017
• Est. completion date: March 15, 2021

Study information

• Verified date: January 2024
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: March 15, 2021
• Est. primary completion date: March 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• hospitalized patients with suspicion of thrombocytopenia drug

• consent signed

Exclusion Criteria:

• Thrombocytopenia plants such as secondary to the following molecules: antineoplastic (except oxaliplatin which gives TIM), immunosuppressants.

• Induced thrombocytopenia heparin and IIb / IIIa glycoproteins (abciximab, tirofiban, epifibatide).

• Presence of anti platelet antibodies allogeneic or autoimmune which are part of the MAIPA test.

• Patient exposed to at least one suspect molecule does not exist in water-soluble form or drug to which the metabolite is suspected

• Patients transfused (plasma, platelets) for less than a month

• Patients with an other bloodline

Related Conditions & MeSH terms

• Thrombocytopenia

Intervention

Biological:
• blood sample
15 ml of blood

Locations

Country	Name	City	State
France	CHU de Saint Etienne	Saint Etienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TITIM test positivity	TITIM test is considered positive when there is a decrease in platelet counts at least 10%.	at baseline