Thrombocytopenia Drug Immune Validation of New Biological Test Diagnostic

NCT ID: NCT02862353

Last Updated: 2024-01-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 8 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-10-25
• Study Completion Date: 2021-03-15

Brief 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

Thrombocytopenia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

patients with thrombocytopenia drug

blood sample

Intervention Type: BIOLOGICAL

15 ml of blood

Interventions

blood sample

15 ml of blood

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Claude LAMBERT, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Saint Etienne

Locations

CHU de Saint Etienne

Saint-Etienne, , France

Countries

France

Other Identifiers

2016-A00858-43

Identifier Type: OTHER

Identifier Source: secondary_id

1608040

Identifier Type: -

Identifier Source: org_study_id