TITIM: Thrombocytopenia Drug Immune Validation of New Biological Test Diagnostic

Sponsor
Centre Hospitalier Universitaire de Saint Etienne (Other)
Overall Status
Recruiting
CT.gov ID
NCT02862353
Collaborator
(none)
20
1
58.2
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: blood sample

Study Design

Study Type:
Observational
Anticipated Enrollment :
20 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Thrombocytopenia Drug Immune Validation of New Biological Test Diagnostic
Actual Study Start Date :
Oct 25, 2017
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Sep 1, 2022

Arms and Interventions

Arm Intervention/Treatment
patients with thrombocytopenia drug

Biological: blood sample
15 ml of blood

Outcome Measures

Primary Outcome Measures

  1. TITIM test positivity [at baseline]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU de Saint Etienne Saint Etienne France 42055

Sponsors and Collaborators

  • Centre Hospitalier Universitaire de Saint Etienne

Investigators

  • Principal Investigator: Claude LAMBERT, MD, Centre Hospitalier Universitaire de Saint Etienne

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier:
NCT02862353
Other Study ID Numbers:
  • 1608040
  • 2016-A00858-43
First Posted:
Aug 11, 2016
Last Update Posted:
Jul 19, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Centre Hospitalier Universitaire de Saint Etienne
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 19, 2021