Completed

NCT Number: NCT03863548

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

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.

Completed

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Key information

Conditions

Patients Undergoing Retina/Vitreous Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU dijon Bourgogne

Dijon, 21000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Complication

Other

collection of post-operative bleeding complications

Primary outcomes

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

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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Official study title

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

Acronym: CLOT

Important dates

Study start: 2019
Primary completion: 2019
Study completion: 2019
First posted: Mar 5, 2019
Registry last updated: Feb 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.