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Risk Factors for Thrombosis in Immune Thrombocytopenia (RiFT-ITP)

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ClinicalTrials.gov Identifier: NCT03820960
Recruitment Status : Recruiting
First Posted : January 29, 2019
Last Update Posted : July 30, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

Tracking Information
First Submitted Date January 22, 2019
First Posted Date January 29, 2019
Last Update Posted Date July 30, 2020
Actual Study Start Date February 1, 2019
Estimated Primary Completion Date February 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 29, 2019)
Risk for thrombosis in adult primary ITP patients treated with ITP treatment [ Time Frame: from July 2009 until June 2015 ]
Number of first hospitalization for arterial and veinous thrombosis in patients treated with ITP treatment
Original Primary Outcome Measures
 (submitted: January 28, 2019)
Risk for thrombosis in adult primary ITP patients treated with ITP treatment [ Time Frame: from July 2009 until June 2015 ]
First hospitalization for arterial and veinous thrombosis in patients treated with ITP treatment
Change History
Current Secondary Outcome Measures
 (submitted: January 29, 2019)
Risk thrombosis in adult primary ITP patients treated with TPO-RAs. [ Time Frame: from July 2009 until June 2015 ]
Number of first hospitalization for arterial and veinous thrombosis in patients treated with ITP patients treated with TPO-RAs.
Original Secondary Outcome Measures
 (submitted: January 28, 2019)
Risk thrombosis in adult primary ITP patients treated with TPO-RAs. [ Time Frame: from July 2009 until June 2015 ]
First hospitalization for arterial and veinous thrombosis in patients treated with ITP patients treated with TPO-RAs.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Risk Factors for Thrombosis in Immune Thrombocytopenia
Official Title Risk Factors for Thrombosis in Immune Thrombocytopenia
Brief Summary

Immune thrombocytopenia (ITP) is a rare autoimmune disease (annual incidence: 3-4/105 inhabitants) leading to an increased risk of spontaneous bleeding. ITP is said "primary" when not associated to other systemic disease (lymphoma, systemic autoimmune disease, chronic infectious disease…). First-line treatment is based on corticosteroids. Intravenous immunoglobulin (IVIg) is added in case of serious bleeding. In about 70% of adult cases, ITP becomes persistent or chronic (lasting >3 months and >12 months, respectively). Second-line treatments are then indicated. Among them, thrombopoietin-receptor agonists (TPO-RAs), romiplostim and eltrombopag are increasingly used. Splenectomy is used as ultimate treatment.

Paradoxically, the risk of thrombosis is higher in ITP patients in comparison with the general population, due to the release of young hyperactive platelets from bone marrow. The incidence of thrombosis in ITP patients has been estimated between 0.5 and 3/100 patients-years. However, risk factors for thrombosis in ITP are not known, except splenectomy that is used in very few patients now. The role of other ITP treatments in thrombosis occurrence has been evoked, particularly for corticosteroids and IVIg. TPO-RAs have been associated with a risk of thrombosis in clinical trials and pharmacovigilance studies, even in case of low or normal platelet count. However, this risk has not been measured in the real-life practice, adjusted for other risk factors for thrombosis.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Observational population-based study in France in the French Adult Immune THrombocytopenia (FAITH) cohort from July 2009 until June 2015. The FAITH study identifies since July 2009 all incident primary ITP adults in France within the national health insurance database (Système National d'Informations Inter-Régimes de l'Assurance Maladie, SNIIRAM, >66 million inhabitants).
Condition Immune Thrombocytopenia
Intervention Not Provided
Study Groups/Cohorts Not Provided
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: January 28, 2019)
700
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 2021
Estimated Primary Completion Date February 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Incident primary ITP adults

Exclusion Criteria:

  • Secondary as well as prevalent ITP patients on July, 30th 2009 are excluded by the algorithm
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Guillaume Moulis, MD 5 61 77 58 94 ext 33 moulis.g@chu-toulouse.fr
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03820960
Other Study ID Numbers RC31/17/0148
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 Not Provided
Responsible Party University Hospital, Toulouse
Study Sponsor University Hospital, Toulouse
Collaborators Not Provided
Investigators
Principal Investigator: Guillaume Moulis, MD University Hospital, Toulouse
PRS Account University Hospital, Toulouse
Verification Date July 2020