Oral 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.
ID
Bron
Verkorte titel
Aandoening
Rhegmatogenous retinal detachment.
Ondersteuning
Rotterdams Oogheelkundig Instituut
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Levels of dabigatran in vitreous, subretinal fluid and plasma. <br>
Antithrombin activity in vitreous and subretinal fluid and plasma.
Achtergrond van het onderzoek
Coagulation 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.
Doel van het onderzoek
Oral 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.
Onderzoeksopzet
Perioperative.
Onderzoeksproduct en/of interventie
Dabigatran etexilate (Pradaxa®) 220 mg once 2, 4 or 8 hours before surgery.
Publiek
Schiedamsevest 180
J.C. Meurs, van
Schiedamsevest 180
Rotterdam 3011 BH
The Netherlands
+31 (0)10 4017777
vanMeurs@oogziekenhuis.nl
Wetenschappelijk
Schiedamsevest 180
J.C. Meurs, van
Schiedamsevest 180
Rotterdam 3011 BH
The Netherlands
+31 (0)10 4017777
vanMeurs@oogziekenhuis.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- Age > 18 years
- Informed consent
- Needing surgery for a rhegmatogenous retinal detachment (scleral buckle surgery or vitrectomy).
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- 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
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL4673 |
| NTR-old | NTR4825 |
| CCMO | NL48418.078.14 |
| OMON | NL-OMON40980 |