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Comparison Two Point of Care Coagulation Monitoring Systems - the ROTEM Sigma and the Quantra Devic

NCT04210830 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 35

Last updated 2019-12-26

No results posted yet for this study

Summary

Human Research Project Risk Category A. In this study no additional intervention or treatment are performed. The whole blood samples are taken from a routinely placed arterial catheter. The blood loss caused by the two additional blood samples is estimated with 2x 2.7ml. The Risk for the patients to participate in this study is minimal.

Clinical observational study of a point of care in vitro diagnostic device, the Quantra®system (Quantra), that received the CE Mark in April 2017 and is approved by the Swiss Medic for clinical use. The Quantra estimates the coagulation strength of whole blood by sonorheometry technology applying a series of ultrasound pulses to a whole blood sample and measuring its stiffness by returning echoes.

Conditions

  • Non Inferiority of the Quantra Device

Interventions

DIAGNOSTIC_TEST

Quantra-Device

Point of Care Coagulation Monitoring System

Sponsors & Collaborators

  • Klinik Hirslanden, Zurich

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-01
Primary Completion
2019-10-03
Completion
2019-10-03

Countries

  • 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 NCT04210830 on ClinicalTrials.gov