Thrombocytopenia Drug Immune Validation of New Biological Test Diagnostic (TITIM)

January 16, 2024 updated by: Centre Hospitalier Universitaire de Saint Etienne

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

8

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Saint Etienne, France, 42055
        • CHU de Saint Etienne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

patients with thrombocytopenia drug

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patients with thrombocytopenia drug
Biological: blood sample
15 ml of blood

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
TITIM test positivity
Time Frame: at baseline
TITIM test is considered positive when there is a decrease in platelet counts at least 10%.
at baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 25, 2017

Primary Completion (Actual)

March 15, 2021

Study Completion (Actual)

March 15, 2021

Study Registration Dates

First Submitted

July 29, 2016

First Submitted That Met QC Criteria

August 8, 2016

First Posted (Estimated)

August 11, 2016

Study Record Updates

Last Update Posted (Actual)

January 17, 2024

Last Update Submitted That Met QC Criteria

January 16, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1608040
  • 2016-A00858-43 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe