Retinal DetachmentNCT01020656
Anticoagulant and Antiplatelet Agents in Patients Undergoing Vitreoretinal Surgery
An observational study of Retinal Detachment, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
Purpose: To establish the prevalence of anticoagulant, aspirin, and clopidogrel use in patients undergoing vitreoretinal surgery, and to compare the outcome of peribulbar anesthesia between users and non-users. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Retinal Detachment
- How many people
- 206 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2009to Jun 2009
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: We analyzed the chart of 239 eyes (206 patients) which underwent posterior segment surgery with peribulbar anesthesia.
Who may be able to join
- Take or no anticoagulant treatment before surgery,
- Vitreoretinal surgery
Who cannot join
- No surgery
- Anesthetic complication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Maintenance of Anticoagulant and Antiplatelet Agents for Patients Undergoing Vitreoretinal Surgery
Purpose: To establish the prevalence of anticoagulant, aspirin, and clopidogrel use in patients undergoing vitreoretinal surgery, and to compare the outcome of peribulbar anesthesia between users and non-users.
- Conditions
- Retinal Detachment
- Keywords
- anticoagulant agents, antiplatelet agents, vitreoretinal surgery, Patients suffered from retinal detachment
- Medical subject headings
- Retinal Detachment
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 |
|---|---|---|
| group 1 | patients with no anticoagulants used as the control group | |
| group 2 | patients treated with anticoagulant therapy (warfarin, fluindone, acenocoumarol) | |
| group 3 | patients treated with aspirin | |
| group 4 | patients treated with clopidogrel therapy | |
| group 5 | patients treated with both anticoagulant and aspirin medications | |
| group 6 | patients treated with both anticoagulant and clopidogrel medications | |
| group 7 | patients treated with both aspirin and clopidogrel medications |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2009 (estimated)
- Study startJan 2009
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinal DetachmentStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01020656
- Sponsor's protocol ID
- MARIE02
- Status last verified
- Nov 2009
- First submitted
- 24 Nov 2009
- Last updated
- 25 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maintenance of Anticoagulant and Antiplatelet Agents for Patients Undergoing Vitreoretinal Surgery
- ClinicalTrials.gov ID
- NCT01020656
- Acronym / sponsor ID
- MARIE02
- Conditions
- Retinal Detachment
- Keywords
- anticoagulant agents, antiplatelet agents, vitreoretinal surgery, Patients suffered from retinal detachment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 25 Nov 2009 (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.
Purpose: To establish the prevalence of anticoagulant, aspirin, and clopidogrel use in patients undergoing vitreoretinal surgery, and to compare the outcome of peribulbar anesthesia between users and non-users.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| group 1 | – | –patients with no anticoagulants used as the control group |
| group 2 | – | –patients treated with anticoagulant therapy (warfarin, fluindone, acenocoumarol) |
| group 3 | – | –patients treated with aspirin |
| group 4 | – | –patients treated with clopidogrel therapy |
| group 5 | – | –patients treated with both anticoagulant and aspirin medications |
| group 6 | – | –patients treated with both anticoagulant and clopidogrel medications |
| group 7 | – | –patients treated with both aspirin and clopidogrel medications |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We analyzed the chart of 239 eyes (206 patients) which underwent posterior segment surgery with peribulbar anesthesia.
Key inclusion criteria (2 listed)
- Take or no anticoagulant treatment before surgery,
- Vitreoretinal surgery
Key exclusion criteria (2 listed)
- No surgery
- Anesthetic complication
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
Not reported in the source record.
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 25 Nov 2009.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Retinal Detachment, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
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 2 inclusion and 2 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 25 Nov 2009. 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 France. 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.
Where can I read the original study information?
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 25 Nov 2009.