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NCT06466824 Clinical Trial

Observational Study on the Outcome of Patients With ITP Who Underwent Splenectomy After 2010

Primary Immune Thrombocytopenia Clinical Trial

Official title:
Observational Study on the Outcome of Patients With Primary Immune Thrombocytopenia (ITP) Who Underwent Splenectomy After January 1st, 2010

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06466824
Other study ID # ITP1324
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date September 2024
Est. completion date March 2025

Study information
Verified date June 2024
Source Gruppo Italiano Malattie EMatologiche dell'Adulto
Contact Paola Fazi
Phone 0670390528
Email p.fazi@gimema.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Retrospective data collection on ITP patients who underwent splenectomy from 01/01/2010 to 12/31/2022. The expected enrollment period is 6 months. The observation period of the enrolled patients is at least 1 year.

Description:

Observational, longitudinal, retrospective study on ITP patients. Patients with ITP who underwent splenectomy from 01/01/2010 to 12/31/2022 will be enrolled. All useful data will be collected exclusively through consultation of outpatient medical records. The expected enrollment period is 6 months. The observation period of the enrolled patients is at least 1 year.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 157
Est. completion date March 2025
Est. primary completion date March 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients aged = 18 years - Patients with primary ITP according to international criteria [2], who underwent to splenectomy from 01/01/2010 to 12/31/2022. - Obtaining Informed Consent. Exclusion Criteria: - none

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Gruppo Italiano Malattie EMatologiche dell'Adulto

Outcome
Type Measure Description Time frame Safety issue
Primary evaluation of complications' incidence after splenectomy Determine the percentage and incidence of thrombotic, hemorrhagic and infectious complications occurring during the patient's follow-up at 90 days
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