drugset / Trial / NCT02438098

Rivaroxaban in Bariatric Surgery

NCT02438098

NaSingle-groupOpen-labelPrevention

Summary

Until now there ist no systematic investigation of the pharmacokinetic parameters of Rivaroxaban in obese patient undergoing bariatric surgery. The aim of this study is to investigate the pharmacokinetic and pharmacodynamic parameters of rivaroxaban in obese patients before and after bariatric surgery. Patients receive the day before the surgical intervention the first dose of Rivaroxaban (10mg). During the following 24 hours, 9 blood samples are taken. The second tablet Rivaroxaban is administered on the third postoperative day, followed again by 9 blood samples during the next 24 hours. All other blood samples are taken independent from this clinical trial as part of the standard medical treatment during the hospitalization. The hospital stay will not be extended by the study. The outpatient regular follow-up takes place one month after surgery and is combined with the last study visit.

Timeline

Start
2015-06
Primary completion
2015-11
Completion
2015-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Rivaroxaban Other / unclassified 10 mg Oral