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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?


- candidate number19566
- NTR NumberNTR4825
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR30-sep-2014
- Secondary IDsNL48418.078.14 OZR-2013-27
- Public TitleDoes oral administration of dabigatran etexilate, a direct thrombin inhibitor, achieve clinical significant concentrations of dabigatran and thrombin inhibiting activity in vitreous and subretinal fluid?
- Scientific TitleDoes oral administration of dabigatran etexilate, a direct thrombin inhibitor, achieve clinical significant concentrations of dabigatran and thrombin inhibiting activity in vitreous and subretinal fluid?
- ACRONYMDabigatran & Ocular Accessibility
- hypothesisOral administration of dabigatran etexilate in patients with a rhegmatogenous retinal detachment leads to clinical significant dabigatran levels and thrombin inhibiting activity in the vitreous and subretinal fluid.
- Healt Condition(s) or Problem(s) studiedRhegmatogenous retinal detachment
- 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, NSAIDs, SSRIs, oral corticosteroids).
- History of stomach ulcer/ bleeding
- Patients with renal function (CrCL) < 50 mL/min
- Age > 75 years
- 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
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-nov-2014
- planned closingdate30-apr-2015
- Target number of participants24
- InterventionsDabigatran etexilate (PradaxaŽ) 220 mg once 2, 4 or 8 hours before surgery.
- Primary outcomeLevels of dabigatran in vitreous, subretinal fluid and plasma.
Antithrombin activity in vitreous and subretinal fluid and plasma.
- Secondary outcomeNone.
- TimepointsPerioperative.
- Trial web site
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESDr. J.C. Meurs, van
- CONTACT for SCIENTIFIC QUERIESDr. J.C. Meurs, van
- Sponsor/Initiator Oogziekenhuis Rotterdam (OZR), Rotterdams Oogheelkundig Instituut (ROI)
- Funding
(Source(s) of Monetary or Material Support)
Combined Ophthalmic Research Rotterdam (CORR)
- PublicationsMulder VC, Kluft C, van Etten PG, La Heij EC, van Meurs JC. Higher vitreous concentrations of dabigatran after repeated oral administration. Acta Ophthalmol. 2017; 95(4): e345-e346.
- Brief summaryCoagulation factor thrombin is thought to play an important role in the development of proliferative vitreoretinopathy (PVR). The direct thrombin inhibitor dabigatran is therefore an interesting potential drug candidate. It is investigated whether oral administration of dabigatran etexilate (single dose, 220 mg) in patients with a rhegmatogenous retinal detachment leads to clinical significant dabigatran levels and thrombin inhibiting activity in the vitreous and subretinal fluid. During surgery, a vitreous or subretinal fluid sample will be taken, and a blood sample.
- Main changes (audit trail)
- RECORD30-sep-2014 - 22-okt-2017


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