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

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ClinicalTrials.gov Identifier: NCT02862353
Recruitment Status : Recruiting
First Posted : August 11, 2016
Last Update Posted : July 22, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne

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
Thrombocytopenia Biological: blood sample

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Thrombocytopenia Drug Immune Validation of New Biological Test Diagnostic
Actual Study Start Date : October 25, 2017
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

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




Primary Outcome Measures :
  1. TITIM test positivity [ Time Frame: at baseline ]
    TITIM test is considered positive when there is a decrease in platelet counts at least 10%.


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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with thrombocytopenia drug
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02862353


Contacts
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Contact: Claude LAMBERT, MD (0)4 77 12 05 13 ext +33 calude.lambert@chu-st-etienne.fr
Contact: Arnauld GARCIN (0)4 77 12 02 86 arnauld.garcin@chu-st-etienne.fr

Locations
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France
CHU de Saint Etienne Recruiting
Saint Etienne, France, 42055
Contact: Claude LAMBERT, MD    (0)4 77 12 05 13      
Sub-Investigator: Anne-Emmanuelle BERGER, MD         
Sub-Investigator: Sandrine ACASSAT, MD         
Principal Investigator: Claude LAMBERT, MD         
Sub-Investigator: Elodie DE MAGALHAES, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Investigators
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Principal Investigator: Claude LAMBERT, MD Centre Hospitalier Universitaire de Saint Etienne

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Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT02862353    
Other Study ID Numbers: 1608040
2016-A00858-43 ( Other Identifier: ANSM )
First Posted: August 11, 2016    Key Record Dates
Last Update Posted: July 22, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
Validation new test
Additional relevant MeSH terms:
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Thrombocytopenia
Blood Platelet Disorders
Hematologic Diseases