8 results
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
To compare the effect of paclitaxel plus MORAb-003 to paclitaxel plus placebo on progression free survival (PFS) as determined by RECIST in subjects who are in a first platinum-resistant or refractory relapse of ovarian cancer.
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 "…
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 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…
Safety: To provide scientific evidence that use of the VAS is safe as measured by the incidence of early-onset serious adverse events (SAEs).Effectiveness: To provide scientific evidence that use of the VAS provides an effective treatment for…
To establish that recovery time from a bronchoprofocation test is faster with HFNC compared to no interfention