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Clinical Trials/NCT03863548
NCT03863548
Completed
Not Applicable

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

Centre Hospitalier Universitaire Dijon1 site in 1 country748 target enrollmentJanuary 8, 2019

Overview

Phase
Not Applicable
Intervention
complication
Conditions
Patients Undergoing Retina/Vitreous Surgery
Sponsor
Centre Hospitalier Universitaire Dijon
Enrollment
748
Locations
1
Primary Endpoint
Occurrence of intra-operative and postoperative hemorrhagic complications in retina/vitreous surgery
Status
Completed
Last Updated
2 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 8, 2019
End Date
July 19, 2019
Last Updated
2 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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

Arms & Interventions

Continuation of antithrombotic drugs

operation carried out without stopping anticoagulants

Intervention: complication

Stop anti thrombotic drugs

operation performed with stopping the anticoagulants

Intervention: complication

Outcomes

Primary Outcomes

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

Time Frame: Through study completion, an average of 8 months

Study Sites (1)

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