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

NCT ID: NCT06466824

Last Updated: 2024-06-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 157 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-09-30
• Study Completion Date: 2025-03-31

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.

Conditions

Primary Immune Thrombocytopenia

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gruppo Italiano Malattie EMatologiche dell'Adulto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nicola Vianelli

Role: PRINCIPAL_INVESTIGATOR

UO Ematologia AOU Policlinico S.Orsola-Malpighi di Bologna

Central Contacts

Paola Fazi

Role: CONTACT

p.fazi@gimema.it

0670390528

Enrico Crea

Role: CONTACT

e.crea@gimema.it

0670390514

Other Identifiers

ITP1324

Identifier Type: -

Identifier Source: org_study_id