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CompletedNCT00986635Updated Apr 8, 2011

Effect of Rivaroxaban on Coagulation Parameters- an ex Vivo Study

An observational study in Differences in Laboratory Coagulation Parameters, sponsored by Johann Wolfgang Goethe University Hospital. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-04-08.

Sponsored by Johann Wolfgang Goethe University Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
100
Ages
18 Years and older
Sex
All
01

Study summary

Rivaroxaban represent a new class of anticoagulation agents. As an oral direct factor Xa inhibitor it has been effective in preventing venous thromboembolism in patients undergoing elective orthopaedic surgery. This ex vivo study is undertaken to investigate the ex-vivo effects of Xarelto® on different coagulation parameters.

Read the detailed description

To validate the effects of Rivaroxaban on coagulation parameters plasma samples of patients after hip or knee replacement surgery treated with Rivaroxaban 10 mg/d are investigated.

Plasma samples are obtained by blood collection before, after 2 hours and after 12 hours after Rivaroxaban dosing in steady state (on 3rd - 5th day).

Several techniques, including clot-based tests, chromogenic assays and ELISA´s are used for coagulation assays in our coagulation laboratory Frankfurt/Main. The influence of Rivaroxaban on different coagulation assays should be investigated in our coagulation laboratory.

02

Conditions studied

  • Differences in Laboratory Coagulation Parameters

Keywords

  • Activated partial thromboplastin time
  • Thrombin clotting Time
  • Anti-Xa-activity
  • Factor X-activity
  • Factor XIII-activity
  • Antithrombin (based on factor II)
  • Antithrombin (based on factor X<9
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In context

Lead sponsor

Johann Wolfgang Goethe University Hospital is the lead sponsor of 158 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

patients after hip or knee replacement surgery

Eligibility criteria

Inclusion Criteria:

  • patients after hip or knee replacement surgery treated with Rivaroxaban 10 mg/d
  • must be able to accept blood sampling
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
100 participants (estimated)
Biospecimen retention
Samples without dna
06

Study locations

1 site
  • University Hospital Frankfurt
    Frankfurt am Main, 60590, Germany
07

References and documents

Publications

  • Mani H, Hesse C, Stratmann G, Lindhoff-Last E. Ex vivo effects of low-dose rivaroxaban on specific coagulation assays and coagulation factor activities in patients under real life conditions. Thromb Haemost. 2013 Jan;109(1):127-36. doi: 10.1160/TH12-04-0228. Epub 2012 Nov 8. PubMed 23138190 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 8, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00986635
Lead sponsor
Johann Wolfgang Goethe University Hospital
First posted
Sep 30, 2009
Start date
Sep 2009
Primary completion
Jun 2010
Completion
Apr 2011
Last update
Apr 8, 2011

Study contacts

Helen Mani, PhD
principal investigator · Johann Wolfgang Goethe University Hospital Frankfurt/Main Germany

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2009. You cannot join it, but the record below documents what was studied.

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