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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 19, 2021
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne

Tracking Information
First Submitted Date July 29, 2016
First Posted Date August 11, 2016
Last Update Posted Date July 19, 2021
Actual Study Start Date October 25, 2017
Estimated Primary Completion Date September 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 8, 2016)
TITIM test positivity [ Time Frame: at baseline ]
TITIM test is considered positive when there is a decrease in platelet counts at least 10%.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Thrombocytopenia Drug Immune Validation of New Biological Test Diagnostic
Official Title Thrombocytopenia Drug Immune Validation of New Biological Test Diagnostic
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:

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.

Sampling Method Non-Probability Sample
Study Population patients with thrombocytopenia drug
Condition Thrombocytopenia
Intervention Biological: blood sample
15 ml of blood
Study Groups/Cohorts patients with thrombocytopenia drug
Intervention: Biological: blood sample
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: August 8, 2016)
20
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 2022
Estimated Primary Completion Date September 2022   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
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
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT02862353
Other Study ID Numbers 1608040
2016-A00858-43 ( Other Identifier: ANSM )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party Centre Hospitalier Universitaire de Saint Etienne
Original Responsible Party Same as current
Current Study Sponsor Centre Hospitalier Universitaire de Saint Etienne
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Claude LAMBERT, MD Centre Hospitalier Universitaire de Saint Etienne
PRS Account Centre Hospitalier Universitaire de Saint Etienne
Verification Date July 2021