Thrombocytopenia Drug Immune Validation of New Biological Test Diagnostic

NCT02862353 | Completed

• 2 other identifiers: 16080402016-A00858-43
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

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

Keywords

Validation new test

Outcome Measures

Primary Outcomes (1)

• TITIM test positivity

  TITIM test is considered positive when there is a decrease in platelet counts at least 10%.

  at baseline

Study Arms (1)

patients with thrombocytopenia drug

Biological: blood sample

Interventions

blood sample BIOLOGICAL

15 ml of blood

patients with thrombocytopenia drug

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with thrombocytopenia drug

You may qualify if:

• hospitalized patients with suspicion of thrombocytopenia drug
• consent signed

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

CHU de Saint Etienne

Saint-Etienne, 42055, France

Location

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.

MeSH Terms

Conditions

Thrombocytopenia

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Blood Platelet Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Cytopenia

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Claude LAMBERT, MD

  Centre Hospitalier Universitaire de Saint Etienne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2016
• First Posted: August 11, 2016
• Study Start: October 25, 2017
• Primary Completion: March 15, 2021
• Study Completion: March 15, 2021
• Last Updated: January 17, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)