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

• Conditions: Patients Undergoing Retina/Vitreous Surgery
• Interventions: Other: complication

• Registration Number: NCT03863548
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-08
• Status Verified: 2019-03
• Study First Submitted: 2019-03-04
• Study First Submitted QC: 2019-03-04
• Last Update Submitted: 2019-03-04
• Study First Posted: 2019-03-05
• Last Update Posted: 2019-03-05
• Primary Completion: 2019-09
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1500

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Stop anti thrombotic drugs	complication	operation performed with stopping the anticoagulants
Continuation of antithrombotic drugs	complication	operation carried out without stopping anticoagulants

Primary Outcome Measures

Name	Time	Method
Occurrence of intra-operative and postoperative hemorrhagic complications in retina/vitreous surgery	Through study completion, an average of 8 months

Trial Locations

Locations (1)

CHU dijon Bourgogne; 🇫🇷 Dijon, France