Seroprevalence Hepatitis E Infection in Healthy Blood Donors

Hepatitis E Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03601221
• Other study ID #: HEV-TI-2018
• Status: Completed
• Start date: May 29, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: March 2020
• Source: Ente Ospedaliero Cantonale, Bellinzona
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1447
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2018
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis E

Intervention

Other:
• Sample collection
Collection of one sampling pouch from each blood donor

Locations

Country	Name	City	State
Switzerland	Swiss Transfusion SRC Canton Ticino	Lugano,

Sponsors (3)

Lead Sponsor	Collaborator
Ente Ospedaliero Cantonale, Bellinzona	Clinical Trial Unit Ente Ospedaliero Cantonale, Swiss Transfusion SRC

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HEV blood incidence	HEV incidence assessed through a single periferal blood sample from each donor	One year
Secondary	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.	Five years
Secondary	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	Five years
Secondary	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	One year