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?

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? - Dabigatran & Ocular Accessibility

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON40980

Enrollment

Registered

2014-03-13

Start date

2014-10-06

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

proliferative vitreoretinopathy

Interventions

Dabigatran etexilate (Pradaxa®) 220 mg once.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Age >= 18 years, - Informed consent, - Needing surgery for a rhegmatogenous retinal detachment (scleral buckle surgery or vitrectomy)

Exclusion criteria

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) 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.

Design outcomes

Primary

Measure	Time frame
Dabigatran levels and thrombin inhibiting activity in the vitreous or subretinal fluid.	—

Secondary

Measure	Time frame
Dabigatran level in plasma.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)