Risk Factors for Thrombosis in Immune Thrombocytopenia (RiFT-ITP)
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| ClinicalTrials.gov Identifier: NCT03820960 |
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Recruitment Status :
Completed
First Posted : January 29, 2019
Last Update Posted : September 5, 2021
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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.
| Condition or disease |
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| Immune Thrombocytopenia |
| Study Type : | Observational |
| Actual Enrollment : | 10039 participants |
| Observational Model: | Case-Control |
| Time Perspective: | Retrospective |
| Official Title: | Risk Factors for Thrombosis in Immune Thrombocytopenia |
| Actual Study Start Date : | February 1, 2019 |
| Actual Primary Completion Date : | February 28, 2021 |
| Actual Study Completion Date : | March 31, 2021 |
- 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
- 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 |
Inclusion Criteria:
- Incident primary ITP adults
Exclusion Criteria:
- Secondary as well as prevalent ITP patients on July, 30th 2009 are excluded by the algorithm
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
| France | |
| University Hospital Toulouse | |
| Toulouse, France | |
| Principal Investigator: | Guillaume Moulis, MD | University Hospital, Toulouse |
| Responsible Party: | University Hospital, Toulouse |
| ClinicalTrials.gov Identifier: | NCT03820960 |
| Other Study ID Numbers: |
RC31/17/0148 |
| First Posted: | January 29, 2019 Key Record Dates |
| Last Update Posted: | September 5, 2021 |
| Last Verified: | September 2021 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Thrombosis |
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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 |