Risk Factors for Thrombosis in Immune Thrombocytopenia

Immune Thrombocytopenia Clinical Trial

— RiFT-ITP  

Official title:

Risk Factors for Thrombosis in Immune Thrombocytopenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03820960
• Other study ID #: RC31/17/0148
• Status: Completed
• Start date: February 1, 2019
• Est. completion date: March 31, 2021

Study information

• Verified date: September 2021
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10039
• Est. completion date: March 31, 2021
• Est. primary completion date: February 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Incident primary ITP adults

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Immune Thrombocytopenia
• Purpura, Thrombocytopenic, Idiopathic
• Thrombocytopenia
• Thrombosis

Locations

Country	Name	City	State
France	University Hospital Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

References & Publications (1)

Lafaurie M, Maquet J, Baricault B, Ekstrand C, Christiansen CF, Linder M, Bahmanyar S, Nørgaard M, Sailler L, Lapeyre-Mestre M, Sommet A, Moulis G. Risk factors of hospitalisation for thrombosis in adults with primary immune thrombocytopenia, including di — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Risk for thrombosis in adult primary ITP patients treated with ITP treatment	Number of first hospitalization for arterial and veinous thrombosis in patients treated with ITP treatment	from July 2009 until June 2015
Secondary	Risk thrombosis in adult primary ITP patients treated with TPO-RAs.	Number of first hospitalization for arterial and veinous thrombosis in patients treated with ITP patients treated with TPO-RAs.	from July 2009 until June 2015