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

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

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.

Study Overview

• Status: Unknown
• Conditions: Patients Undergoing Retina/Vitreous Surgery
• Intervention / Treatment: Other: complication

• Study Type: Observational
• Enrollment (Anticipated): 1500

Contacts and Locations

• Study Contact: Name: Catherine CREUZOT-GARCHER; Phone Number: +33 380295173; Email: catherine.creuzot-garcher@chu-dijon.fr

Study Locations

• France
  • Dijon, France, 21000
    • Recruiting
    • Chu Dijon Bourgogne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing surgery

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Continuation of antithrombotic drugs; operation carried out without stopping anticoagulants	Other: complication; collection of post-operative bleeding complications
Stop anti thrombotic drugs; operation performed with stopping the anticoagulants	Other: complication; collection of post-operative bleeding complications

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Dijon

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 8, 2019
• Primary Completion (ANTICIPATED): September 1, 2019
• Study Completion (ANTICIPATED): December 1, 2019

Study Registration Dates

• First Submitted: March 4, 2019
• First Submitted That Met QC Criteria: March 4, 2019
• First Posted (ACTUAL): March 5, 2019

Study Record Updates

• Last Update Posted (ACTUAL): March 5, 2019
• Last Update Submitted That Met QC Criteria: March 4, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: LOUISON CFSR 2017

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No