To demonstrate non-inferiority of continuation of platelet inhibiting drugs in eyelid surgery regarding the risk of haemorrhagic complications.
ID
Source
Brief title
Condition
- Eye disorders NEC
- Eye therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Peroperative bleeding
Postoperative bleeding
Postoperative bruising
Secondary outcome
Retrobulbar haemorrhage
Result of surgery
Duration of surgery
Cardiac or cerebral ischaemic event
Background summary
Retrobulbar bleeding can cause total functional loss of the eye. In order to
reduce that risk, antiplatelet medication is commonly discontinued
perioperatively in oculoplastic surgery. This practise may have to be
reconsidered, however, because 1) the incidence of serious haemorrhagic
complications may be low and 2) the risk of serious systemic ischaemic events
is temporarily increased. Prospective studies are needed to develop
evidence-based guidelines for the use of platelet inhibiting drugs in
combination with oculoplastic surgery.
Study objective
To demonstrate non-inferiority of continuation of platelet inhibiting drugs in
eyelid surgery regarding the risk of haemorrhagic complications.
Study design
Prospective, double-masked, randomized, placebo-controlled trial.
Intervention
Continuation (group 1) or discontinuation (group 2) of platelet inhibiting
drugs.
Study burden and risks
Participants of group 2 will be subject to the current procedure for eyelid
surgery in The Rotterdam Eye Hospital. Therefore, no additional risk is
involved. Patients of group 1 may be subject to a lower relative risk of
ischaemic events and higher relative risk of haemorrhagic events due to eyelid
surgery. Burden is low (two extra visits which take about 10-15 minutes each).
Schiedamse Vest 180
3011 BH Rotterdam
Nederland
Schiedamse Vest 180
3011 BH Rotterdam
Nederland
Listed location countries
Age
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
Exclusion criteria
concomitant use of other anticoagulant drugs (coumarin derivatives, clopidogrel, dipyridamol, NSAIDs)
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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2009-009986-32-NL |
| CCMO | NL26858.078.09 |