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Completed

NCT Number: NCT03601221

Seroprevalence Hepatitis E Infection in Healthy Blood Donors

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).

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Key information

Conditions

Hepatitis E Digestive System Diseases Hepatitis Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Swiss Transfusion SRC Canton Ticino

Lugano, 6900, Switzerland

About this study

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).

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sample collection

Other

Collection of one sampling pouch from each blood donor

Primary outcomes

  1. HEV blood incidence

    Time frame: One year

    HEV incidence assessed through a single periferal blood sample from each donor

Secondary outcomes

  1. 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.

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Ente Ospedaliero Cantonale, Bellinzona

Other

Collaborators

  • Clinical Trial Unit Ente Ospedaliero Cantonale
  • Swiss Transfusion SRC

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Jul 26, 2018
Registry last updated
Mar 31, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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