Does oral administration of dabigatran etexilate, a direct thrombin inhibitor, achieve clinical significant concentrations of dabigatran and thrombin inhibiting activity in vitreous and subretinal fluid?
Completed
- Conditions
- proliferative vitreoretinopathy10015917
- Registration Number
- NL-OMON40980
- Lead Sponsor
- Oogziekenhuis Rotterdam
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 24
Inclusion Criteria
- Age >= 18 years,
- Informed consent,
- Needing surgery for a rhegmatogenous retinal detachment (scleral buckle surgery or vitrectomy)
Exclusion Criteria
- Using other anticoagulants (e.g. acenocoumarol, heparin etc),
- Using medication that increases risk of GI bleeding (e.g. aspirin, NSAID*s, SSRI*s, oral corticosteroids).
- History of stomach ulcer/ bleeding
- Patients with renal function (CrCL) < 50 mL/min,
- Age > 75
- Hepatic impairment,
- Hypersensitivity to the active substance or to any of the excipients,
- Concomitant treatment with systemic ketoconazole, cyclosporine, itraconazole, tacrolimus and dronedarone,
- Lesion or condition at significant risk of major bleeding.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Dabigatran levels and thrombin inhibiting activity in the vitreous or<br /><br>subretinal fluid.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Dabigatran level in plasma.</p><br>