Comparison of the ROTEM Sigma and the Quantra System in Cardiac Surgery

Blood Loss, Surgical Clinical Trial

Official title:

Comparison of Methods and Coagulation Analysis Between ROTEM Sigma and Quantra System in Cardiac Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04310124
• Other study ID #: HEMCS-ZU
• Status: Completed
• Start date: December 17, 2018
• Est. completion date: December 5, 2019

Study information

• Verified date: March 2020
• Source: HemoSonics LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study compares the results of the Quantra System with the QPlus Cartridge to results obtained with the ROTEM sigma in patients undergoing cardia surgery utilizing cardiopulmonary bypass.

Description:

The Quantra System is a fully integrated and automated in vitro diagnostic device which uses SEER Sonorheometry, an ultrasound-based technology, to characterize the viscoelastic properties of a whole blood sample during coagulation. The QPlus Cartridge was developed to monitor hemostasis during major surgical procedures in adult patients. The cartridge consists of four independent channels, each containing different sets of reagents, which provide four measurements performed in parallel yielding six parameters that depict the functional status of a patient's coagulations system.

This single-center, prospective, observational study will evaluate the performance of the Quantra System with the QPlus Cartridge as compared to comparable measures determined using the ROTEM sigma.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: December 5, 2019
• Est. primary completion date: July 16, 2019
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients scheduled for cardiac surgery needing a cardiopulmonary bypass

• Age 18 years or older

• Written consent of the participation after clarification about the study

Exclusion Criteria:

• No consent to participate

• No German comprehension

Related Conditions & MeSH terms

• Blood Loss, Surgical

Intervention

Diagnostic Test:
• Quantra System
Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care.

Locations

Country	Name	City	State
Switzerland	Klinik Im Park Zurich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
HemoSonics LLC

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of Quantra Clot Time results to ROTEM INTEM Clot Time results	Coagulation function assessed by Quantra and ROTEM sigma	Baseline
Primary	Comparison of Quantra Clot Time results to ROTEM INTEM Clot Time results	Coagulation function assessed by Quantra and ROTEM sigma	End of cardiopulmonary bypass
Primary	Comparison of Quantra Heparinase Clot Time results to ROTEM HEPTEM Clot Time results	Coagulation function assessed by Quantra and ROTEM sigma	Baseline
Primary	Comparison of Quantra Heparinase Clot Time results to ROTEM HEPTEM Clot Time results	Coagulation function assessed by Quantra and ROTEM sigma	End of cardiopulmonary bypass
Primary	Comparison of Quantra Clot Stiffness results to ROTEM EXTEM A10 results	Coagulation function assessed by Quantra and ROTEM sigma	Baseline
Primary	Comparison of Quantra Clot Stiffness results to ROTEM EXTEM A10 results	Coagulation function assessed by Quantra and ROTEM sigma	End of cardiopulmonary bypass
Primary	Comparison of Quantra Fibrinogen Contribution to Clot Stiffness results to ROTEM FIBTEM A10 results	Coagulation function assessed by Quantra and ROTEM sigma	Baseline
Primary	Comparison of Quantra Fibrinogen Contribution to Clot Stiffness results to ROTEM FIBTEM A10 results	Coagulation function assessed by Quantra and ROTEM sigma	End of cardiopulmonary bypass
Primary	Comparison of Quantra Platelet Contribution to Clot Stiffness results to ROTEM PLATEM (calculated) results	Coagulation function assessed by Quantra and ROTEM sigma	Baseline
Primary	Comparison of Quantra Platelet Contribution to Clot Stiffness results to ROTEM PLATEM (calculated) results	Coagulation function assessed by Quantra and ROTEM sigma	End of cardiopulmonary bypass
Primary	Comparison of Quantra time to results to ROTEM sigma time to results	Time from start of test to final results	Baseline
Primary	Comparison of Quantra time to results to ROTEM sigma time to results	Time from start of test to final results	End of cardiopulmonary bypass