Actively Recruiting

Age: 18Years +
All Genders
NCT07354893

Evaluation of the Effectiveness of an Educational Intervention in Splenectomized Patients

Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2026-02-02

100

Participants Needed

2

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The absence or dysfunction of the spleen is associated with a substantially increased risk of invasive infections that may rapidly progress to fulminant sepsis, including overwhelming post-splenectomy infection (OPSI), a medical emergency with high mortality. Although the risk is greatest in the first two years after splenectomy, it persists lifelong. Preventing infections in patients with anatomical or functional asplenia requires an integrated strategy that includes patient education, early recognition of symptoms, behavioral measures, antibiotic prophylaxis when indicated, and vaccination. Post-splenectomy immunization has been shown to reduce OPSI incidence. Regional and international guidelines recommend vaccination against pneumococcus, Haemophilus influenzae type b, meningococcus (B and ACWY), herpes zoster, diphtheria-tetanus-pertussis, measles-mumps-rubella-varicella, and annual influenza. However, adherence to these recommendations is frequently suboptimal, often due to limited awareness among patients and healthcare professionals. This study involves the intra-hospital vaccination team providing structured vaccination consultations to splenectomized patients hospitalized at the Fondazione Policlinico Universitario "A. Gemelli" IRCCS. During ward consultations, patients receive an educational intervention on asplenia-related infectious risks and preventive measures, supported by standardized informational materials. Effectiveness is evaluated using a pre-post questionnaire assessing knowledge and awareness. Patients completing the vaccination pathway at the outpatient clinic also complete a questionnaire assessing their experience with vaccination management in an intra-hospital setting.

CONDITIONS

Official Title

Evaluation of the Effectiveness of an Educational Intervention in Splenectomized Patients

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients (≥18 years old)
  • Patients splenectomized at FPG with a requested vaccination consultation during hospitalization
  • Patients who provide signed informed consent for participation and data processing
Not Eligible

You will not qualify if you...

  • Minor patients
  • Lack of signed informed consent for participation and data processing
  • Patients splenectomized at other healthcare facilities

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Fondazione Policlinico Universitario A. Gemelli IRCCS

Rome, Lazio, Italy, 00168

Actively Recruiting

2

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, Italy, 00168

Actively Recruiting

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Research Team

L

LAURENTI PATRIZIA, PROFESSOR

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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Evaluation of the Effectiveness of an Educational Intervention in Splenectomized Patients | DecenTrialz