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Seroprevalence Hepatitis E Infection in Healthy Blood Donors

Observational Study on Seroprevalence of Hepatitis E Infection in Healthy Blood Donors in the Canton Ticino

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03601221
Enrollment
1447
Registered
2018-07-26
Start date
2018-05-29
Completion date
2019-12-31
Last updated
2020-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis E

Brief summary

This is a HEV seroprevalence in the health donors in the Canton Ticino study. The pre-donation sampling pouch of each blood donor coming form the Cantone Ticino region will be collected and tested for HEV serology (IgM and IgG).

Detailed description

Pre-donation sampling pouch of fresh and stored frozen plasma collected within the last 5 years will be tested for HEV IgG serology at the National Reference Laboratory of the Blood Transfusion Services SRC in Berne Collected data will be used to determine HEV seroprevalence, actual and in the last 5 years, in the Canton Ticino and to investigate trend and pattern of the HEV infection (seroprevalence by different regional areas, comparison with national HEV data, and correlation with age, sex and place of residence).

Interventions

OTHERSample collection

Collection of one sampling pouch from each blood donor

Sponsors

Swiss Transfusion SRC
CollaboratorOTHER
Clinical Trial Unit Ente Ospedaliero Cantonale
CollaboratorOTHER
Ente Ospedaliero Cantonale, Bellinzona
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL

Inclusion criteria

* Healthy and voluntary blood donors * Subjects living in the Canton Ticino * Inclusion criteria for blood donation * Signed informed consent of the STCRS SI for blood donation

Exclusion criteria

*

Design outcomes

Primary

MeasureTime frameDescription
HEV blood incidenceOne yearHEV incidence assessed through a single periferal blood sample from each donor

Secondary

MeasureTime frameDescription
change in the blood incidence of HEVFive yearsDetermine the change in the incidence of HEV in the Canton Ticino region in the last 5 years analysing the blood sample of the donors.
Geogarphical distribution of the HEV measured in the blood sampleFive yearsDetermination of the distribution of the HEV infection in different geographical areas of the Canton Ticino analysing donor blood samples
Trend of the HEV infection measured in the blood sampleOne yearEvaluation of the trend of the HEV infection in the CantoneTicino compared to other Swiss cantons

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026