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 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…
Phase Ia: (dose escalation):- To determine the maximum tolerated dose (MTD) and a recommended Phase II dose (RP2D) for M3814 (also referred to as MSC2490484A) in combination with fractionated palliative radiotherapy (RT) for tumors or metastases…
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