Aim of this clinical Trial is the assessment of rivaroxaban PK/PD parameters in patients 6-8 months after bariatric surgery
Weight loss after bariatric surgery can putatively alter drug disposition of rivaroxaban. This may be due to an altered intestinal adaptations several months after the surgical procedure. The aim of this clinical trial is to investigate pharmacokinetic and pharmacodynamic parameters after single application of 10 mg rivaroxaban in patients with prior bariatric intervention (Roux-en-y-gastric bypass or sleeve gastrectomy 6-8 months ago). PK/PD parameters will be assessed during 12 hours after application of rivaroxaban.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
13
At study month 7 (+/-1 month), patients receive at 8 a.m. a single dose of 10 mg rivaroxaban. Study specific blood tubes are sampled the same day at the indicated time points from T -1h to T 12h.
University Hospital, Inselspital Berne
Bern, Switzerland
AUC of rivaroxaban
Time frame: 1 year
Cmax of rivaroxaban
Time frame: 1 year
Tmax of rivaroxaban
Time frame: 1 year
Prothrombin time (PT)
Time frame: 1 year
Activated partial thromboplastin time (aPTT)
Time frame: 1 year
Levels of Prothrombin fragment (F1+F2)
Time frame: 1 year
Levels of Thrombin-antithrombin-complexes (TAT)
Time frame: 1 year
Levels of D-Dimers
Time frame: 1 year
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