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Platelet inhibiting drugs in eyelid surgery.


- candidate number6268
- NTR NumberNTR1932
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR4-aug-2009
- Secondary IDsMEC-2011-182 Erasmus MC
- Public TitlePlatelet inhibiting drugs in eyelid surgery.
- Scientific TitleThe continuation of platelet inhibiting drugs in eyelid surgery. An observational study
- ACRONYMN?A
- hypothesisContinuation of platelet inhibiting drugs in eyelid surgery is not inferior regarding the risk of haemorrhagic complications.
- Healt Condition(s) or Problem(s) studiedEyelid Surgery, Platelet inhibitors, Haemorrhagische complicaties
- Inclusion criteria1. Daily use of acetylsalicylic acid or carbasalate calcium;
2. Scheduled for surgical correction of ectropion or entropion, or for non-cosmetic upperlid blepharoplasty without fat excision.
- Exclusion criteria1. Concomitant use of other anticoagulant drugs (coumarin derivatives, clopidogrel, dipyridamol, Non-Steroidal Anti-Inflammatory Drugs);
2. Concomitant use of selective serotonin reuptake inhibitors (SSRI's);
3. Known systemic disease that affects haemostasis;
4. Prescribing physician advising against discontinuation (A record will be kept of these excluded patients, together with the prescribing physician's reasons for advising negatively);
5. Obvious fat prolapses that need to be excised in case of blepharoplasty;
6. General anaesthesia.
- mec approval receivedno
- multicenter trialno
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 1-jun-2009
- planned closingdate31-mei-2011
- Target number of participants324
- InterventionsAcetylsalicylic acid /placebo.
- Primary outcome1. Peroperative bleeding;
2. Postoperative bleeding;
3. Postoperative bruising.
- Secondary outcome1. Retrobulbar haemorrhage;
2. Result of surgery;
3. Duration of surgery;
4. Cardiac or cerebral ischaemic event.
- Timepoints1. Presentation;
2. Preop (14 days);
3. Perop;
4. Postop (5 days);
5. Postop (6 weeks).
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESDr. O. Weijtens
- CONTACT for SCIENTIFIC QUERIESDr. O. Weijtens
- Sponsor/Initiator Oogziekenhuis Rotterdam (OZR)
- Funding
(Source(s) of Monetary or Material Support)
Stichting Wetenschappelijk Onderzoek het Oogziekenhuis
- PublicationsN/A
- Brief summaryRationale:
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;
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.
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.
Study population:
Patients, using platelet inhibiting drugs, due for eyelid surgery (n=324).
Intervention:
Continuation (group 1) or discontinuation (group 2) of platelet inhibiting drugs.
Main study parameters:
Peroperative bleeding, postoperative bleeding/bruising.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
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).
- Main changes (audit trail)12-sep-2014: Study design changed from RCT into prospective observational. - AB

1-mei-2015:

Inclusion:
Old:
1. Daily use of acetylsalicylic acid or carbasalate calcium;
2. Scheduled for surgical correction of ectropion or entropion, or for non-cosmetic upperlid blepharoplasty without fat excision.
New:
1. Use of platelet inhibiting drugs.
2. Scheduled for surgical correction of ectropion or entropion, or for non-cosmetic upperlid blepharoplasty without fat excision.

Exclusion:
Old:
1. Concomitant use of other anticoagulant drugs (coumarin derivatives, clopidogrel, dipyridamol, Non-Steroidal Anti-Inflammatory Drugs);
2. Concomitant use of selective serotonin reuptake inhibitors (SSRI's);
3. Known systemic disease that affects haemostasis;
4. Prescribing physician advising against discontinuation (A record will be kept of these excluded patients, together with the prescribing physician's reasons for advising negatively);
5. Obvious fat prolapses that need to be excised in case of blepharoplasty;
6. General anaesthesia.
New:
NA

Interventions:
Old:
Acetylsalicylic acid /placebo.
New:
None

Primary outcome:
Old:
1. Peroperative bleeding;
2. Postoperative bleeding;
3. Postoperative bruising.
New:
1. Peroperative bleeding;
2. Postoperative bleeding;
3. Other postoperative adverse event.


Secondary outcome:
Old:
1. Retrobulbar haemorrhage;
2. Result of surgery;
3. Duration of surgery;
4. Cardiac or cerebral ischaemic event.

New:
1. Retrobulbar haemorrhage;
2. Result of surgery;
3. Reduced visual acuity;
4. Cardiac or cerebral ischaemic event.

Timepoints:
Old:
1. Presentation;
2. Preop (14 days);
3. Perop;
4. Postop (5 days);
5. Postop (6 weeks).
New:
1. Perop;
2. Postop (6 weeks).

Brief summary:
New:
Rationale: Guidelines for perioperative use of platelet inhibiting drugs have been changed recently, and procedures in eyelid surgery in The Rotterdam Eye Hospital have been adjusted accordingly. Adverse events that may be related to eyelid surgery and the use of platelet inhibiting drugs will be systematically registered (and compared with retrospective data when platelet inhibiting drugs used to be temporarily discontinued).
Objective: To systematically and consistently record adverse events in relation to eyelid surgery and platelet inhibiting medication.
Study design: Prospective observational, and retrospective data retrieval.
Study population: Retrospective (2009-2010): patients that underwent eyelid surgery with platelet inhibiting medication discontinued. Prospective: patients using platelet inhibiting medication scheduled for eyelid surgery.
Intervention: NA.
Main study parameters/endpoints: Incidence of adverse events. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: None.
- RECORD4-aug-2009 - 22-okt-2017


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