7 results
To evaluate the inter- and intra-subject variability in pharmacokinetics (PK) and pharmacodynamics (PD) of study drug following a two-period repeated single dose of 2 mg delivered by subcutaneous (SC) injection in healthy volunteers.
To assess the normalization (reversal) of coagulation assays upon administration of two dosages of Prothrombin Complex Concentratre (PCC, Cofact®) in healthy volunteers treated with either rivaroxaban or apixaban
Study questionWhat is the effect of a single administration of prothrombin complex concentrate (CoFact) on the anticoagulant effect of a novel oral thrombin inhibitor (Dabigatran) and a novel oral factor Xa inhibitor (Rivaroxaban) in healthy human…
To investigate in a randomized controlled trial, whether giving Cofact pre-operatively can reduce the bloodloss and transfusion requirements during orthotopic liver transplantation. Also we investigate the safety of Cofact in this patient population…
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 "…
The objective of this study is to validate a new patented prototype prosthetic leg on lateral balance control, and to gain insight into lateral balance in prosthetic walking.The following research questions will be investigated:1. What differences…
To test whether the clinical outcome of lower fixed dose of PCC is superior to higher variable dose of PCC, for VKA related bleeding in a randomized setting. Secondary objectives include the comparison of INR after administration of PCC, time to…