Bleeding as Complication to Anticoagulation TherapyNCT02107651
Reporting of Adverse Events in Patients Treated With New Oral Anticoagulants
An observational study of Bleeding as Complication to Anticoagulation Therapy, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
Serious adverse events in patients treated with new oral anticoagulants are underreported. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bleeding as Complication to Anticoagulation Therapy
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2013to Apr 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients admitted for GI bleeding while in treatment with NOAC
Who may be able to join
- patients admitted for GI bleeding while in treatment with NOAC
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Serious Adverse Events in Patients Treated With New Oral Anticoagulants Are Underreported
Serious adverse events in patients treated with new oral anticoagulants are underreported.
Read the detailed description
The study investigates if serious adverse events in patients treated with NOAC are reported to the Health and Medicines Authority.
- Keywords
- Bleeding, Anticoagulation
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| NOAC | Patients admitted for GI bleeding while in treatment with NOAC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients admitted with adverse event reported to authorities
Measured: Within one year of admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2014 (estimated)
- Study startJan 2013
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bleeding as Complication to Anticoagulation TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thue Bisgaard, Hvidovre University Hospital
- Investigators
- Bisgaard Thue, Ph.D, Principal investigator, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02107651
- Sponsor's protocol ID
- 01675-HVH-2012-010-999
- Status last verified
- Apr 2014
- First submitted
- 4 Apr 2014
- Last updated
- 24 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25370961
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serious Adverse Events in Patients Treated With New Oral Anticoagulants Are Underreported
- ClinicalTrials.gov ID
- NCT02107651
- Acronym / sponsor ID
- 01675-HVH-2012-010-999
- Keywords
- Bleeding, Anticoagulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 8 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NOAC | – | –Patients admitted for GI bleeding while in treatment with NOAC |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients admitted for GI bleeding while in treatment with NOAC
Key inclusion criteria (1 listed)
- patients admitted for GI bleeding while in treatment with NOAC
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of patients admitted with adverse event reported to authorities
Time frame: Within one year of admission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2014.
- Derived from this study: PubMed 25370961Bay-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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bisgaard Thue, Ph.D principal investigator
Hvidovre University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bleeding as Complication to Anticoagulation Therapy, run by Hvidovre University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients admitted with adverse event reported to authorities (time frame: Within one year of admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02107651, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2014.