Seroprevalence Hepatitis E Infection in Healthy Blood Donors

March 30, 2020 updated by: Ente Ospedaliero Cantonale, Bellinzona

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

1447

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Lugano,, Switzerland, 6900
        • Swiss Transfusion SRC Canton Ticino

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Healthy and voluntary blood donors

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HEV blood incidence
Time Frame: One year
HEV incidence assessed through a single periferal blood sample from each donor
One year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in the blood incidence of HEV
Time Frame: 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.
Five years
Geogarphical distribution of the HEV measured in the blood sample
Time Frame: Five years
Determination of the distribution of the HEV infection in different geographical areas of the Canton Ticino analysing donor blood samples
Five years
Trend of the HEV infection measured in the blood sample
Time Frame: One year
Evaluation of the trend of the HEV infection in the CantoneTicino compared to other Swiss cantons
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ente Ospedaliero Cantonale, Bellinzona

Collaborators

Clinical Trial Unit Ente Ospedaliero Cantonale
Swiss Transfusion SRC

Investigators

  • Study Director: Florian Bihl, MD, Ente Ospedaliero Cantonale, Bellinzona

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 29, 2018

Primary Completion (ACTUAL)

December 31, 2018

Study Completion (ACTUAL)

December 31, 2019

Study Registration Dates

First Submitted

July 5, 2018

First Submitted That Met QC Criteria

July 17, 2018

First Posted (ACTUAL)

July 26, 2018

Study Record Updates

Last Update Posted (ACTUAL)

March 31, 2020

Last Update Submitted That Met QC Criteria

March 30, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HEV-TI-2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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