French Observational Study of Complications Associated With Anticoagulants and Antiplatelet Treatment in Retina/Vitreous Surgery

NCT ID: NCT03863548

Last Updated: 2019-03-05

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 1500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-01-08
• Study Completion Date: 2019-12-31

Brief Summary

Anticoagulants and antiplatelet treatments are frequently prescribed treatments to prevent or treat thromboembolic complications and reduce morbidity and mortality related to cardiovascular risk factors. In retina/vitreous surgery, there are rare but potentially serious risks of hemmorrhagic complication resulting in irreversible loss of visual acuity. There is no clear consensus on how to proceed during the perioperative period with regard to the continuation or discontinuation of anticoagulant and antiplatelet treatments in these types of surgery. the purpose of the study is to identify complications at 1 month depending on the type of surgery with or without discontinuation of antithrombotic treatments. Practitioners are not asked to change their modus operandi. The hypothesis is that there is no excess risk of peri- or post-operative hemorrhage in retino-vitreous surgery in patients treated with antithrombotic compared to untreated patients and that therefore discontinuation of these treatments before surgery is not necessary.

Conditions

Patients Undergoing Retina/Vitreous Surgery

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Continuation of antithrombotic drugs

operation carried out without stopping anticoagulants

complication

Intervention Type: OTHER

collection of post-operative bleeding complications

Stop anti thrombotic drugs

operation performed with stopping the anticoagulants

complication

Intervention Type: OTHER

collection of post-operative bleeding complications

Interventions

complication

collection of post-operative bleeding complications

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• person who has expressed willingness to participate
• person over 18 years of age
• person with a retinal-vitreous condition requiring scheduled surgery (epi-retinal membrane surgery, vitreous traction surgery, macular hole surgery).

Exclusion Criteria

• person subject to legal protection (curatorship, guardianship)
• person deemed mentally incompetent
• pregnant, parturient or breastfeeding woman
• adult unwilling or unable to consent
• patient who has already participated in the study
• person with a physical or mental disability that does not allow participation.
• a person who has participated in any study of an experimental medical product within the previous 3 months
• person who experiences any of the following during the ophthalmological examination:

• severe or proliferating diabetic retinopathy
• intra-vitreal hemorrhage
• tractional retinal detachment
• subretinal or retrohyaloidal hematoma.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU dijon Bourgogne

Dijon, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Catherine CREUZOT-GARCHER

Role: CONTACT

catherine.creuzot-garcher@chu-dijon.fr

+33 380295173

Facility Contacts

Catherine CREUZOT GARCHER, MD

Role: primary

catherine.creuzot-garcher@chu-dijon.fr

3.80.29.51.73 ext. +33

Other Identifiers

LOUISON CFSR 2017

Identifier Type: -

Identifier Source: org_study_id