NCT06466824

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
157

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2024

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 14, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 20, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

June 20, 2024

Status Verified

June 1, 2024

Enrollment Period

6 months

First QC Date

June 14, 2024

Last Update Submit

June 14, 2024

Conditions

Primary Immune Thrombocytopenia

Keywords

splenectomy

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Condition Hierarchy (Ancestors)

Purpura, ThrombocytopenicPurpuraBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesThrombotic MicroangiopathiesThrombocytopeniaBlood Platelet DisordersCytopeniaHemorrhagic DisordersAutoimmune DiseasesImmune System DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsSkin ManifestationsSigns and Symptoms

Study Officials

  • Nicola Vianelli

    UO Ematologia AOU Policlinico S.Orsola-Malpighi di Bologna

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Paola Fazi

CONTACT

0670390528p.fazi@gimema.it

Enrico Crea

CONTACT

0670390514e.crea@gimema.it

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2024

First Posted

June 20, 2024

Study Start

September 1, 2024

Primary Completion

March 1, 2025

Study Completion

March 1, 2025

Last Updated

June 20, 2024

Record last verified: 2024-06