8 results
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 "…
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
We aim to validate the quantitative OC3T tissue characterization method in a clinical setting, using independent imaging as a validation standard. The development of this technique was developed based on ex vivo data, and in vivo validation is…
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…
Primary ObjectiveThis is a confirmatory trial to establish non-inferior efficacy of remimazolam compared with propofol for induction and maintenance of GA for the purpose of elective surgery in patients classes III and IV based on the American…
The objectives are:* to show non-inferiority of remimazolam compared with propofol in terms of successful maintenance of sedation defined as a Narcotrend index of 60 or less during at least 85% of the maintenance time without the use of rescue…
The primary objective is to quantify the remimazolam exposure-response relationship with and without remifentanil in regard to various stages of MOAA/S for procedural and ICU sedation and general anaesthesiaSecondary objectives are:- Quantification…