Risk Factors for Thrombosis in Immune Thrombocytopenia

NCT ID: NCT03820960

Last Updated: 2021-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

10039 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-02-01

Study Completion Date

2021-03-31

Brief Summary

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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

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Conditions

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Immune Thrombocytopenia

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Incident primary ITP adults

Exclusion Criteria

* Secondary as well as prevalent ITP patients on July, 30th 2009 are excluded by the algorithm
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Toulouse

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Guillaume Moulis, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

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University Hospital Toulouse

Toulouse, , France

Site Status

Countries

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France

References

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Lafaurie M, Maquet J, Baricault B, Ekstrand C, Christiansen CF, Linder M, Bahmanyar S, Norgaard M, Sailler L, Lapeyre-Mestre M, Sommet A, Moulis G. Risk factors of hospitalisation for thrombosis in adults with primary immune thrombocytopenia, including disease-specific treatments: a French nationwide cohort study. Br J Haematol. 2021 Nov;195(3):456-465. doi: 10.1111/bjh.17709. Epub 2021 Aug 12.

Reference Type RESULT
PMID: 34386974 (View on PubMed)

Other Identifiers

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RC31/17/0148

Identifier Type: -

Identifier Source: org_study_id

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