An observational study in Hepatitis E, sponsored by Ente Ospedaliero Cantonale, Bellinzona. Completed at 1 site in Switzerland. Per ClinicalTrials.gov, last updated 2020-03-31.
Sponsored by Ente Ospedaliero Cantonale, Bellinzona · Observational
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).
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).
37 studies on the registry are indexed under Hepatitis E; 9 are open to participants now.
This study's enrollment of 1,447 is above the median of 436 across 11 observational studies indexed under Hepatitis E.
Browse Hepatitis E studies →Ente Ospedaliero Cantonale, Bellinzona is the lead sponsor of 38 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Healthy and voluntary blood donors
Inclusion Criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Collection of one sampling pouch from each blood donor
HEV blood incidence
HEV incidence assessed through a single periferal blood sample from each donor
Time frame: One year
change in the blood incidence of HEV
Determine the change in the incidence of HEV in the Canton Ticino region in the last 5 years analysing the blood sample of the donors.
Time frame: Five years
Geogarphical distribution of the HEV measured in the blood sample
Determination of the distribution of the HEV infection in different geographical areas of the Canton Ticino analysing donor blood samples
Time frame: Five years
Trend of the HEV infection measured in the blood sample
Evaluation of the trend of the HEV infection in the CantoneTicino compared to other Swiss cantons
Time frame: One year
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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Ente Ospedaliero Cantonale, Bellinzona