Reporting of Adverse Events in Patients Treated With New Oral Anticoagulants

NCT ID: NCT02107651

Last Updated: 2014-04-24

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

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-31

Study Completion Date

2014-04-30

Brief Summary

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Serious adverse events in patients treated with new oral anticoagulants are underreported.

Detailed Description

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The study investigates if serious adverse events in patients treated with NOAC are reported to the Health and Medicines Authority.

Conditions

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Bleeding as Complication to Anticoagulation Therapy

Study Design

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Observational Model Type

CASE_ONLY

Study Groups

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NOAC

Patients admitted for GI bleeding while in treatment with NOAC

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* patients admitted for GI bleeding while in treatment with NOAC

Exclusion Criteria

* none
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hvidovre University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Thue Bisgaard

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bisgaard Thue, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Hvidovre University Hospital

Locations

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Hvidovre Hospital University of Copenhagen

Hvidovre, , Denmark

Site Status

Countries

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Denmark

References

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Bay-Nielsen M, Kampmann JP, Bisgaard T. Gastrointestinal bleedings during therapy with new oral anticoagulants are rarely reported. Dan Med J. 2014 Nov;61(11):A4952.

Reference Type DERIVED
PMID: 25370961 (View on PubMed)

Other Identifiers

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01675-HVH-2012-010-999

Identifier Type: -

Identifier Source: org_study_id

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