NCT03601221

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,447

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 29, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 5, 2018

Completed
21 days until next milestone

First Posted

Study publicly available on registry

July 26, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

March 31, 2020

Status Verified

March 1, 2020

Enrollment Period

7 months

First QC Date

July 5, 2018

Last Update Submit

March 30, 2020

Conditions

Hepatitis E

Outcome Measures

Primary Outcomes (1)

  • HEV blood incidence

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

    One year

Secondary Outcomes (3)

  • change in the blood incidence of HEV

    Five years

  • Geogarphical distribution of the HEV measured in the blood sample

    Five years

  • Trend of the HEV infection measured in the blood sample

    One year

Interventions

Sample collectionOTHER

Collection of one sampling pouch from each blood donor

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy and voluntary blood donors

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Swiss Transfusion SRC Canton Ticino

Lugano, 6900, Switzerland

Location

MeSH Terms

Conditions

Hepatitis E

Interventions

Specimen Handling

Condition Hierarchy (Ancestors)

Hepatitis, Viral, HumanVirus DiseasesInfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Florian Bihl, MD

    Ente Ospedaliero Cantonale, Bellinzona

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2018

First Posted

July 26, 2018

Study Start

May 29, 2018

Primary Completion

December 31, 2018

Study Completion

December 31, 2019

Last Updated

March 31, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)