Risk Factors for Thrombosis in Immune Thrombocytopenia

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03820960

Acronym

RiFT-ITP

Enrollment

10039

Registered

2019-01-29

Start date

2019-02-01

Completion date

2021-03-31

Last updated

2021-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Immune Thrombocytopenia

Keywords

Thrombosis

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Incident primary ITP adults

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Risk for thrombosis in adult primary ITP patients treated with ITP treatment	from July 2009 until June 2015	Number of first hospitalization for arterial and veinous thrombosis in patients treated with ITP treatment

Secondary

Measure	Time frame	Description
Risk thrombosis in adult primary ITP patients treated with TPO-RAs.	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.

Countries

France

Outcome results