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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 : April 26, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

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.


Condition or disease
Immune Thrombocytopenia

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Study Type : Observational
Estimated Enrollment : 700 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Risk Factors for Thrombosis in Immune Thrombocytopenia
Actual Study Start Date : February 1, 2019
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : March 2020





Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.



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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
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).
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

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): NCT03820960


Contacts
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Contact: Guillaume Moulis, MD 5 61 77 58 94 ext 33 moulis.g@chu-toulouse.fr

Locations
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France
University Hospital Toulouse Recruiting
Toulouse, France
Contact: Guillaume Moulis, MD         
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
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Principal Investigator: Guillaume Moulis, MD University Hospital, Toulouse

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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT03820960     History of Changes
Other Study ID Numbers: RC31/17/0148
First Posted: January 29, 2019    Key Record Dates
Last Update Posted: April 26, 2019
Last Verified: April 2019

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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 University Hospital, Toulouse:
Thrombosis
Additional relevant MeSH terms:
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Thrombosis
Thrombocytopenia
Purpura, Thrombocytopenic, Idiopathic
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Blood Platelet Disorders
Hematologic Diseases
Purpura, Thrombocytopenic
Purpura
Blood Coagulation Disorders
Thrombotic Microangiopathies
Hemorrhagic Disorders
Autoimmune Diseases
Immune System Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
Signs and Symptoms