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Rivaroxaban in Bariatric Surgery

NCT02438098 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2016-01-08

No results posted yet for this study

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.

Conditions

  • Prophylaxis of Venous Thromboembolism

Interventions

DRUG

Rivaroxaban 10 mg

Patients receive the day before the surgical intervention the first dose of Rivaroxaban (10 mg) p.o. The second tablet Rivaroxaban is administered on the third postoperative day.

Sponsors & Collaborators

  • Centre Hospitalier Universitaire Vaudois

    collaborator OTHER

  • Bayer

    collaborator INDUSTRY

  • Insel Gruppe AG, University Hospital Bern

    lead OTHER

Principal Investigators

  • Dino Kroell, ME · University of Bern

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2015-11-30
Completion
2015-11-30

Countries

  • Switzerland

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02438098 on ClinicalTrials.gov