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

Not yet recruiting

• Conditions: Primary Immune Thrombocytopenia

• Registration Number: NCT06466824
• Lead Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto

Brief 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.

Detailed 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.

Study Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-06-14
• Study First Submitted QC: 2024-06-14
• Last Update Submitted: 2024-06-14
• Study First Posted: 2024-06-20
• Last Update Posted: 2024-06-20
• Study Start: 2024-09
• Primary Completion: 2025-03
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 157

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
evaluation of complications' incidence after splenectomy	at 90 days	Determine the percentage and incidence of thrombotic, hemorrhagic and infectious complications occurring during the patient's follow-up