Splenectomized PatientsSPLE-VACNCT07354893
Evaluation of the Effectiveness of an Educational Intervention in Splenectomized Patients
An observational study of Splenectomized Patients and Splenectomy, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 2 sites in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Splenectomized Patients, Splenectomy, Splenectomy; Status
- What is being tested?
- Educational intervention for asplenic patients
- Type of treatment
- Vaccines
- How many people
- 100 participants
- Where
- 2 sitesItaly
- Study dates
- 13 Jan 2026to 13 Jan 2028
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients splenectomized at the Fondazione Policlinico Universitario A. Gemelli IRCCS, identified during consultation activities in the requesting wards and/or managed by the hospital outpatient vaccination clinic for frail patients.
Who may be able to join
- Adult patients (≥18 years old)
- Patients splenectomized at FPG for whom a vaccination consultation is requested during hospitalization
- Patients who provide signed informed consent to participate in the study and for the processing of personal data for research purposes
Who cannot join
- Minor patients
- Lack of signed informed consent for participation in the study and for the processing of personal data for research purposes
- Patients splenectomized at other healthcare facilities
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy2 sites, 2 recruiting
- Recruiting
Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma, 00168
Patrizia Laurenti
- Recruiting
Fondazione Policlinico Universitario A. Gemelli IRCCS
Rome, Lazio, 00168
Patrizia Laurenti, +390630155701, patrizia.laurenti@policlinicogemelli.it
Patrizia Laurenti
About this study
Official title: Evaluation of an Educational Intervention on Knowledge and Awareness of Infectious Risk in Splenectomized Patients and on Their Satisfaction With Vaccination Management in an Intra-hospital Outpatient Setting.
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.
Read the detailed description
This is a prospective, observational patient registry conducted at a single academic hospital. Adult patients undergoing splenectomy at the Fondazione Policlinico Universitario A. Gemelli IRCCS are consecutively identified through routine inpatient clinical workflows and enrolled after written informed consent.
Clinical, sociodemographic, and vaccination-related data are collected as part of standard care by the intra-hospital vaccination clinic and recorded in a dedicated database using predefined variables. Patient-reported outcomes are assessed using structured questionnaires administered before and after an educational intervention and, for patients completing the vaccination pathway, at the end of follow-up.
The registry allows longitudinal follow-up to monitor patient education, vaccination uptake, completion of recommended schedules, and post-discharge continuity of care. Follow-up data are collected during outpatient visits or, when necessary, via structured telephone interviews.
Data quality is ensured through standardized data collection procedures, use of validated questionnaires, and cross-verification of vaccination data using independent institutional sources. All data are pseudonymized and managed in compliance with applicable data protection regulations. The study is conducted according to Good Clinical Practice, Good Epidemiological Practice, and the Declaration of Helsinki.
- Conditions
- Splenectomized Patients, Splenectomy, Splenectomy; Status, Asplenia
- Being tested
- Educational intervention for asplenic patients
- Keywords
- OPSI, infection risk, Infection Prevention, Preventive measures, Vaccination, asplenia, splenectomy, splenectomized patients, post splenectomy infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational intervention for asplenic patientsOther
an educational intervention aimed at informing patients about the condition of asplenia, the associated infectious risks, and the main preventive measures, with particular emphasis on vaccination prophylaxis. To support the intervention, educational materials will be distributed, including an informational brochure and the "Recommended Vaccinations for Asplenic Patients" schedule.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Infectious Risk Knowledge, Vaccination Attitudes, and Risk Perception Score
Change from baseline to post-intervention in patients' knowledge of infectious risk, attitudes toward vaccination, and perception of infectious risk following an educational and counseling intervention. The outcome is assessed in splenectomized patients identified and/or managed by the intra-hospital outpatient clinic of the Fondazione Policlinico Universitario "A. Gemelli" IRCCS (FPG).
Measure Description:
Infectious Risk and Vaccination Awareness Questionnaire for Splenectomized Patients (specifically developed and validated questionnaire). The total score ranges from 16 to 80, with higher scores indicating greater knowledge, more favorable attitudes toward vaccination, and higher perceived infectious risk.
Measured: 24 months
Secondary outcomes (3)
Patient Experience with Vaccination Prophylaxis Management Score
Patient experience related to the management of vaccination prophylaxis in an intra-hospital outpatient setting, assessed during follow-up outpatient visits.
Measure Description:
Patient Experience with Vaccination Prophylaxis Questionnaire (validated questionnaire derived from the literature). The total score ranges from 13 to 65, with higher scores indicating a more positive patient experience.
Measured: 24 months
Association Between Infectious Risk Knowledge Score and Socio-demographic Characteristics
Correlation between patients' infectious risk knowledge and awareness levels and socio-demographic characteristics (e.g., age, sex, educational level, clinical characteristics), aimed at identifying factors useful for the personalization of educational interventions.
Measure Description:
Infectious Risk and Vaccination Awareness Questionnaire for Splenectomized Patients. Associations will be evaluated using correlation coefficients and regression parameters.
Measured: 24 months
Adherence to the Intra-hospital Vaccination Pathway
Adherence to the intra-hospital vaccination pathway among splenectomized patients managed by the outpatient clinic, including enrollment in the pathway and administration of recommended vaccinations.
Measure Description:
Proportion (expressed in percentage, %) of patients enrolled in the vaccination pathway and proportion of recommended vaccinations administered per patient. Values range from 0% to 100%, with higher percentages indicating greater adherence.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start13 Jan 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion13 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Splenectomized PatientsStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laurenti Patrizia, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Investigators
- LAURENTI PATRIZIA, PROFESSOR, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07354893
- Sponsor's protocol ID
- 8123
- Acronym
- SPLE-VAC
- Status last verified
- Jan 2026
- First submitted
- 12 Jan 2026
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Educational Intervention on Knowledge and Awareness of Infectious Risk in Splenectomized Patients and on Their Satisfaction With Vaccination Management in an Intra-hospital Outpatient Setting.
- ClinicalTrials.gov ID
- NCT07354893
- Acronym / sponsor ID
- SPLE-VAC / 8123
- Conditions
- Splenectomized Patients, Splenectomy, Splenectomy; Status, Asplenia
- Keywords
- OPSI, infection risk, Infection Prevention, Preventive measures, Vaccination, asplenia, splenectomy, splenectomized patients
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 13 Jan 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 13 Jan 2028 (estimated)
- First posted
- 21 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a prospective, observational patient registry conducted at a single academic hospital. Adult patients undergoing splenectomy at the Fondazione Policlinico Universitario A. Gemelli IRCCS are consecutively identified through routine inpatient clinical workflows and enrolled after written informed consent.
Clinical, sociodemographic, and vaccination-related data are collected as part of standard care by the intra-hospital vaccination clinic and recorded in a dedicated database using predefined variables. Patient-reported outcomes are assessed using structured questionnaires administered before and after an educational intervention and, for patients completing the vaccination pathway, at the end of follow-up.
The registry allows longitudinal follow-up to monitor patient education, vaccination uptake, completion of recommended schedules, and post-discharge continuity of care. Follow-up data are collected during outpatient visits or, when necessary, via structured telephone interviews.
Data quality is ensured through standardized data collection procedures, use of validated questionnaires, and cross-verification of vaccination data using independent institutional sources. All data are pseudonymized and managed in compliance with applicable data protection regulations. The study is conducted according to Good Clinical Practice, Good Epidemiological Practice, and the Declaration of Helsinki.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 24 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients splenectomized at the Fondazione Policlinico Universitario A. Gemelli IRCCS, identified during consultation activities in the requesting wards and/or managed by the hospital outpatient vaccination clinic for frail patients.
Key inclusion criteria (3 listed)
- Adult patients (≥18 years old)
- Patients splenectomized at FPG for whom a vaccination consultation is requested during hospitalization
- Patients who provide signed informed consent to participate in the study and for the processing of personal data for research purposes
Key exclusion criteria (3 listed)
- Minor patients
- Lack of signed informed consent for participation in the study and for the processing of personal data for research purposes
- Patients splenectomized at other healthcare facilities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational intervention for asplenic patientsan educational intervention aimed at informing patients about the condition of asplenia, the associated infectious risks, and the main preventive measures, with particular emphasis on vaccination prophylaxis. To support the intervention, educational materials will be distributed, including an informational brochure and the "Recommended Vaccinations for Asplenic Patients" schedule. | Other | – |
Primary outcome
Change in Infectious Risk Knowledge, Vaccination Attitudes, and Risk Perception Score
Time frame: 24 months
Change from baseline to post-intervention in patients' knowledge of infectious risk, attitudes toward vaccination, and perception of infectious risk following an educational and counseling intervention. The outcome is assessed in splenectomized patients identified and/or managed by the intra-hospital outpatient clinic of the Fondazione Policlinico Universitario "A. Gemelli" IRCCS (FPG). Measure Description: Infectious Risk and Vaccination Awareness Questionnaire for Splenectomized Patients (specifically developed and validated questionnaire). The total score ranges from 16 to 80, with higher scores indicating greater knowledge, more favorable attitudes toward vaccination, and higher perceived infectious risk.
3 secondary outcomes
Patient Experience with Vaccination Prophylaxis Management Score
Time frame: 24 months
Association Between Infectious Risk Knowledge Score and Socio-demographic Characteristics
Time frame: 24 months
Adherence to the Intra-hospital Vaccination Pathway
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Splenectomized Patients
RecruitingObservational study
Development of an Italian Questionnaire for Splenectomized Patients Using a Delphi Consensus Method
Splenectomy; Status, Asplenia
RecruitingPhase 3
Research Trial Assessing the Immunogenicity and Safety of Three Meningococcal B Vaccine Strategies Among Patients With Asplenia.
Splenectomy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
LAURENTI PATRIZIA, PROFESSOR principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Splenectomized Patients and Splenectomy, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact LAURENTI PATRIZIA, PROFESSOR (063015.9333, patrizia.laurenti@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Infectious Risk Knowledge, Vaccination Attitudes, and Risk Perception Score (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2026.