Reporting of Adverse Events in Patients Treated With New... | NCT02107651

Studies
Reporting of Adverse Events in Patients Treated With New Oral Anticoagulants

NCT02107651

Sponsor

Hvidovre University Hospital

Status

Completed

Last Update Posted

Apr 24, 2014Estimated

Enrollment

20Actual

Phase

Not provided

Conditions

Bleeding as Complication to Anticoagulation Therapy

Interventions

Not provided

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2013

Primary Completion Date

Apr 2014Actual

Completion Date

Apr 2014Actual

First Submitted Date

Apr 4, 2014

First Submission Date that Met QC Criteria

Apr 7, 2014

First Posted Date

Apr 8, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 23, 2014

Last Update Posted Date

Apr 24, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Label	Type	Description	Intervention Names
NOAC		Patients admitted for GI bleeding while in treatment with NOAC

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Proportion of patients admitted with adverse event reported to authorities		Within one year of admission

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients admitted for GI bleeding while in treatment with NOAC

Exclusion Criteria:

none

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients admitted for GI bleeding while in treatment with NOAC

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bisgaard Thue, Ph.D	Hvidovre University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hvidovre Hospital University of Copenhagen		Hvidovre		2650	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25370961	Derived	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.

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms