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

NCT04210830 | Completed

• 1 other identifier: KlinikHirslande
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (6)

• Equivalence of the results of both devices

  Comparision of the results of the INTEM CT (R) with the Clot Time (Q)

  1 Year

• Equivalence of the results of both devices

  HEPTEM CT (R) was compared with the Heparinase Clot ime (Q)

  1 Year

• Equivalence of results of both devices

  INTEM CT/HEPTEM CT (R) was compared with the Clot Time Ratio (Q)

  1 Year

• Equivalence of results of both devices

  EXTEM A10 (R) was compared with the Clot Stiffness (Q)

  1 Year

• Equivalence of results of both devices

  FIBTEM A10 (R) was compared with the Fibrinogen Contribution to Clot Stiffness (Q)

  1 Year

• Equivalence of results of both devices

  Difference of EXTEM A10 and FIBTEM A10 (R) was compared with the Platelet Contribution to Clot Stiffness (Q)

  1 Year

Secondary Outcomes (3)

• Turnaround time of the measurements

  1 Year

• Turnaround time of the measurements

  1 Year

• Turnaround time of the measurements

  1 Year

Interventions

Quantra-Device DIAGNOSTIC_TEST

Point of Care Coagulation Monitoring System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

cardiac surgery patients

You may qualify if:

• Patients scheduled for cardiac surgery needing a cardiopulmonary bypass
• Age older than18 years
• Written consent of the participation after clarification about the study

You may not qualify if:

• No consent to participate
• No German comprehension
• Known coagulation disorder

Sponsors & Collaborators

• Klinik Hirslanden, Zurich: lead

Study Sites (1)

Klinik Im Park

Zurich, 8027, Switzerland

Location

Related Publications (1)

• Baulig W, Akbas S, Schutt PK, Keul W, Jovic M, Berdat P, von Felten S, Steigmiller K, Ganter MT, Theusinger OM. Comparison of the resonance sonorheometry based Quantra(R) system with rotational thromboelastometry ROTEM(R) sigma in cardiac surgery - a prospective observational study. BMC Anesthesiol. 2021 Oct 28;21(1):260. doi: 10.1186/s12871-021-01469-5.

  PMID: 34711167 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood samples for Measurement the coagulation state of whole blood

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med.

Study Record Dates

• First Submitted: October 3, 2019
• First Posted: December 26, 2019
• Study Start: November 1, 2018
• Primary Completion: October 3, 2019
• Study Completion: October 3, 2019
• Last Updated: December 26, 2019

Record last verified: 2019-12

Locations

CH (1)