Seroprevalence Hepatitis E Infection in Healthy Blood Donors

NCT ID: NCT03601221

Last Updated: 2020-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1447 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-05-29

Study Completion Date

2019-12-31

Brief Summary

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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

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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).

Conditions

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Hepatitis E

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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Sample collection

Collection of one sampling pouch from each blood donor

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Healthy and voluntary blood donors
* Subjects living in the Canton Ticino
* Signed informed consent of the STCRS SI for blood donation
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Swiss Transfusion SRC

OTHER

Sponsor Role collaborator

Clinical Trial Unit Ente Ospedaliero Cantonale

OTHER

Sponsor Role collaborator

Ente Ospedaliero Cantonale, Bellinzona

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Florian Bihl, MD

Role: STUDY_DIRECTOR

Ente Ospedaliero Cantonale, Bellinzona

Locations

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Swiss Transfusion SRC Canton Ticino

Lugano, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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HEV-TI-2018

Identifier Type: -

Identifier Source: org_study_id

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