18 results
The goal of this trial is to collect long-term observational data on the tolerability, safety and efficacy of dabigatran etexilate in a spectrum of patients receiving bileaflet mechanical heart valves. All patients that have completed study 1160.113…
To investigate the effect of dabigatran etexilate on airway inflammation, hemostasis and asthma control in patients with severe asthma.
1) identifying new predictors of ST, in particular of late and very late ST and drug eluting stent thrombosis2) to observe clinical outcome after an episode of a ST
The purpose of this study is to confirm/validate predicted dabigatran trough plasma levels gained after individual dose assignment based on simulations by means of PK data from the RE-LY trial. Based on this validation a final appropriate dosing…
The aim of this phase I study is to assess the extent of intestinal absorption of rivaroxaban and dabigatran etexilate in adult patients with short bowel syndrome and treated with long-term TPN.
To asses the comparability of the estimated dabigatran concentration in plasma via calibrated Hemoclot and the measured dabigatran concentrations assessed in a central lab in patients with moderate renal impairment undergoing primary unilateral…
To test the suitability of OCT for in vivo imaging of the vascularisation and surrounding tissue of burn wounds and scars.
To investigate whether 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.
To provide single dose PK/PD dataTo investigate tolerability and safety of dabigatran etexilate solution in children1 to <12 years of age
To determine whether a single dose of 50 IE/Kg PCC is effective in reversing the anticoagulant effect of Dabigatran Etexilate 300mg b.i.d. taken for 2.5 days, as assessed by two modified skin bleeding assays: the "shed blood" and "…
See section 2.2 of the protocol.The main objective of this study is to compare a DAT regimen of 110mg dabigatran etexilate b.i.d. plus clopidogrel or ticagrelor (110mg DE-DAT) and 150mg dabigatran etexilate b.i.d. plus clopidogrel or ticagrelor (…
See section 2.2. of the protocol.The primary objective of this trial is to assess the safety of an uninterrupted dabigatran etexilate periprocedural anticoagulant regimen compared to an uninterrupted warfarin regimen in NVAF patients undergoing AF…
Primary Objective: To investigate if use of OCT is (cost-)effective in the diagnostic work-up of patients with clinically and dermoscopically suspected basal cell carcinoma (BCC).Secondary Objective(s): To explore if OCT is a more patient friendly…
To identify and define characteristics of ILD on the pCLE and pOCT image of airway wall mucosa and the alveolar compartment and compare this to HRCT imaging and pathology.
See protocol sectie 2.1 & 2.2
In this study we aim to use minimally invasive real-time techniques including OCT, HHGM, eNose and/or GC-MS for the evaluation of the effect of BT and determine response predictors. To evaluate innovative diagnostic techniques that might be able to…
To evaluate management strategies in premenopausal women with heavy menstrual bleeding associated with factor Xa inhibitor therapy.
To investigate the added value of OCT as a non-invasive tool for the diagnosis of recurrent BCC.