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

NCT03863548 | Completed

• 1 other identifier: LOUISON CFSR 2017
• Study Type: observational
• Target: 748
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Occurrence of intra-operative and postoperative hemorrhagic complications in retina/vitreous surgery

  Through study completion, an average of 8 months

Study Arms (2)

Continuation of antithrombotic drugs

operation carried out without stopping anticoagulants

Other: complication

Stop anti thrombotic drugs

operation performed with stopping the anticoagulants

Other: complication

Interventions

complication OTHER

collection of post-operative bleeding complications

Continuation of antithrombotic drugs; Stop anti thrombotic drugs

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing surgery

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

CHU dijon Bourgogne

Dijon, 21000, France

Location

Related Publications (1)

• Louison S, Gabrielle PH, Soudry A, Meillon C, Blanc J, Beal G, Arsene S, Le Mer Y, Berrod JP, Kodjikian L, Creuzot-Garcher C; CFCR Research net. Perioperative risk of bleeding with antithrombotic agents in macular surgery: a national, prospective, multicentre study. Acta Ophthalmol. 2020 Dec;98(8):e991-e997. doi: 10.1111/aos.14434. Epub 2020 Apr 12.

  PMID: 32279459 RESULT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2019
• First Posted: March 5, 2019
• Study Start: January 8, 2019
• Primary Completion: July 19, 2019
• Study Completion: July 19, 2019
• Last Updated: February 4, 2026

Record last verified: 2026-02

Locations

FR (1)