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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03863548
Acronym
CLOT
Enrollment
748
Registered
2019-03-05
Start date
2019-01-08
Completion date
2019-07-19
Last updated
2026-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients Undergoing Retina/Vitreous Surgery

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.

Interventions

OTHERcomplication

collection of post-operative bleeding complications

Sponsors

Centre Hospitalier Universitaire Dijon
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Occurrence of intra-operative and postoperative hemorrhagic complications in retina/vitreous surgeryThrough study completion, an average of 8 months

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026