Seroprevalence Hepatitis E Infection in Healthy Blood Donors

Completed

• Conditions: Hepatitis E

• Registration Number: NCT03601221
• Lead Sponsor: Ente Ospedaliero Cantonale, Bellinzona

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).

Study Timeline

• Study Start: 2018-05-29
• Study First Submitted: 2018-07-05
• Study First Submitted QC: 2018-07-17
• Study First Posted: 2018-07-26
• Primary Completion: 2018-12-31
• Study Completion: 2019-12-31
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-30
• Last Update Posted: 2020-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1447

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

• Exclusion criteria for blood donation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
HEV blood incidence	One year	HEV incidence assessed through a single periferal blood sample from each donor

Secondary Outcome Measures

Name	Time	Method
change in the blood incidence of HEV	Five years	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.
Geogarphical distribution of the HEV measured in the blood sample	Five years	Determination 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 sample	One year	Evaluation of the trend of the HEV infection in the CantoneTicino compared to other Swiss cantons

Trial Locations

Locations (1)

Swiss Transfusion SRC Canton Ticino; 🇨🇭 Lugano,, Switzerland