Continuation of platelet inhibiting drugs in eyelid surgery. A randomized, double-masked, placebo-controlled clinical trial. - Platelet inhibiting drugs in eyelid surgery

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-009986-32-NL

Enrollment

324

Registered

2009-01-30

Start date

2009-06-30

Completion date

Unknown

Last updated

2022-04-19

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

Conditions

Patients, using platelet inhibiting drugs, due for eyelid surgery

Interventions

Product Name: acetylsalicylic acid Pharmaceutical Form: Capsule* Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: · daily use of acetylsalicylic acid or carbasalate calcium · scheduled for surgical correction of ectropion or entropion, or for non-cosmetic upperlid blepharoplasty without fat excision Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: · concomitant use of other anticoagulant drugs (coumarin derivatives, clopidogrel, dipyridamol, Non-Steroidal Anti-Inflammatory Drugs) · known systemic disease that affects haemostasis · prescribing physician advising against discontinuation · obvious fat prolapses that need to be excised in case of blepharoplasty. · general anaesthesia

Design outcomes

Primary

Measure	Time frame
Main Objective: To demonstrate non-inferiority of continuation of platelet inhibiting drugs in eyelid surgery regarding the risk of haemorrhagic complications.;Secondary Objective: To determine whether continuation of platelet inhibiting drugs leads to prolonged duration of eyelid surgery due to excessive intraoperative haemorrhage, and whether it influences the final result of eyelid surgery.;Primary end point(s): Peroperative bleeding Postoperative bleeding Postoperative bruising	—

Measure

Time frame

Main Objective: To demonstrate non-inferiority of continuation of platelet inhibiting drugs in eyelid surgery regarding the risk of haemorrhagic complications.;Secondary Objective: To determine whether continuation of platelet inhibiting drugs leads to prolonged duration of eyelid surgery due to excessive intraoperative haemorrhage, and whether it influences the final result of eyelid surgery.;Primary end point(s): Peroperative bleeding Postoperative bleeding Postoperative bruising

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Countries

Netherlands

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026