Clinical Research Directory

Inclusion criteria SBS single dose: \- patients with SBS (small bowel length of \<2m after Treitz ligament) on long term (\>3 months) PN or fluids who are apixaban-, vitamin K antagonist- and teduglutide naive Inclusion criteria SBS steady-state: \- patients with SBS (small bowel length of \<2m after Treitz ligament) on long term (\>3 months) PN or fluids who are teduglutide naive and who are already taking apixaban 2,5 mg or 5 mg twice daily for ≥ 4 days Inclusion criteria non-SBS single dose: \- healthy individuals without history of GI resections or other conditions associated with impaired absorption, who are apixaban- and vitamin K antagonist naive Inclusion criteria non-SBS steady-state: \- patients without history of gastrointestinal resections or other conditions associated with impaired absorption (= controls), who are already taking apixaban 2,5 mg or 5 mg twice daily for ≥ 4 days Exclusion criteria SBS (single dose+ steady-state): * \<18 years * non-Dutch speaking * recent (\<6 months) major bleeds according with the International Society on Thrombosis and Haemostasis definition of major bleeding in non-surgical patients (20) * creatinine clearance of \< 15 mL/min or dialysis dependent * liver failure classified as Child Pugh C * total bilirubin ≥ 1.77 mg/dL (= 1,5 x upper limit of normal) * presence of coagulopathy and a clinically relevant bleeding risk * pregnancy or lactation * concomitant intake of strong combined inhibitors of CYP3A4 and P-gp * participation in a recent (\<1 month) trial with an investigational product * recent (\<6 months) gastrointestinal surgery * gastrointestinal mucosal disease interfering with absorption (e.g. radio-enteritis, inflammatory bowel disease, celiac disease, …) * gastrointestinal fistulae * SBS with intestinal failure resulting from gastric bypass surgery Exclusion criteria non-SBS (single dose+ steady-state): * \<18 years * non-Dutch speaking * recent (\<6 months) major bleeds according with the International Society on Thrombosis and Haemostasis definition of major bleeding in non-surgical patients (20) * creatinine clearance of \< 15 mL/min or dialysis dependent * liver failure classified as Child Pugh C * total bilirubin ≥ 1.77 mg/dL (= 1,5 x upper limit of normal) * presence of coagulopathy and a clinically relevant bleeding risk * pregnancy or lactation * concomitant intake of strong combined inhibitors of CYP3A4 and P-gp * use of prokinetics, antimotility drugs or opioids * participation in a recent (\<1 month) trial with an investigational product