Observational Study on the Outcome of Patients With ITP W... | NCT06466824

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

NCT06466824

Sponsor

Gruppo Italiano Malattie EMatologiche dell'Adulto

Status

Unknown status

Last Update Posted

Jun 20, 2024Actual

Enrollment

157Estimated

Phase

Not provided

Conditions

Primary Immune Thrombocytopenia

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2024Estimated

Primary Completion Date

Mar 2025Estimated

Completion Date

Mar 2025Estimated

First Submitted Date

Jun 14, 2024

First Submission Date that Met QC Criteria

Jun 14, 2024

First Posted Date

Jun 20, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 14, 2024

Last Update Posted Date

Jun 20, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

157Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with ITP who underwent splenectomy from 01/01/2010 to 12/31/2022 will be enrolled

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Paola Fazi	Contact	0670390528		p.fazi@gimema.it
Enrico Crea	Contact	0670390514		e.crea@gimema.it

Overall Officials

Name	Affiliation	Role
Nicola Vianelli	UO Ematologia AOU Policlinico S.Orsola-Malpighi di Bologna	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D016553	Purpura, Thrombocytopenic, Idiopathic

Ancestor Terms

ID	Term
D011696	Purpura, Thrombocytopenic
D011693	Purpura
D001778	Blood Coagulation Disorders
D006402	Hematologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided