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ROTEM® Sigma Performance Evaluation - Method Comparison With Predicate Device and Reference Intervals

NCT02379104 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 240

Last updated 2017-05-11

No results posted yet for this study

Summary

ROTEM® sigma is a new thromboelastometric coagulation analysis system. The new system is fully automated allowing for a simple and safe operation compared to its predecessor model ROTEM® delta.

Method comparison of ROTEM® sigma with predecessor model ROTEM® delta) - confirmation of equality.

Confirmation of reference intervals of the ROTEM® systems.

Conditions

  • Blood Coagulation Disorders

Interventions

DEVICE

ROTEM sigma

Group Healthy Volunteers: a blood sample is tested with ROTEM sigma Group Patients with expected coagulopathy: a blood sample is tested with ROTEM sigma and ROTEM delta in parallel

Sponsors & Collaborators

  • Tem Innovations GmbH

    lead INDUSTRY

Principal Investigators

  • Volker Friemert, Dr. · Tem Innovations GmbH

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-10-31
Primary Completion
2018-10-31
Completion
2018-12-31

Countries

  • United States
  • Austria
  • Switzerland

Study Locations

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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 NCT02379104 on ClinicalTrials.gov