Pre-surgical Evaluation for the Quantra System in Adult Patients Undergoing Cardiac Surgery

Blood Loss, Surgical Clinical Trial

Official title:

Pre-surgical Evaluation for the Quantra System in Adult Patients Undergoing Cardiac Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03931031
• Other study ID #: HEMCS-017
• Status: Completed
• Start date: March 21, 2019
• Est. completion date: June 27, 2020

Study information

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

Clinical Trial Summary

This study will evaluate the performance of the Quantra System comprised of the Quantra Hemostasis Analyzer with the QPlus Cartridge in patients taking anitplatelet medication that are scheduled to undergo cardiac surgery.

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 Quantra 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 coagulation system.

This single-site, prospective, observational study will evaluate the performance of the Quantra System as compared to standard coagulation tests and comparable measures determined using TEG in patients taking antiplatelet medication that are scheduled to undergo cardiac surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 27, 2020
• Est. primary completion date: April 7, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subject is scheduled for elective cardiac surgery utilizing cardiopulmonary bypass, including the placement of a ventricular assist device

• Subject was identified as taking antiplatelet medication, specifically a P2Y12 inhibitor such that a TEG Platelet Mapping test is prescribed prior to surgery to assess possible platelet inhibition

• Subject is = 18 years

• Subject is willing to participate and he/she has signed a consent form

Exclusion Criteria:

• Subject is younger that 18 years

• Subject is unable to provide written informed consent

• Subject is incarcerated at the time of the study

• Subject is pregnant

• Subject is currently enrolled in a distinct study that might confound the results of the proposed study

• Subject is affected by a condition that, in the opinion of the clinical team, may pose additional risks.

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
United States	Huntsville Hospital	Huntsville	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
HemoSonics LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of Quantra Clot Time test results to TEG test results.	Coagulation function assessed by Quantra and TEG.	Prior to surgery (Baseline)
Primary	Comparison of Quantra Clot Stiffness test results to TEG test results.	Coagulation function assessed by Quantra and TEG.	Prior to surgery (Baseline)
Primary	Comparison of Quantra Clot Time and Clot Stiffness test results to TEG test results.	Coagulation function assessed by Quantra and TEG.	Post-bypass (10 to 20 minutes after protamine administration).
Primary	Comparison of Quantra Clot Time test results to TEG test results.	Coagulation function assessed by Quantra and TEG.	Post-bypass (10 to 20 minutes after protamine administration).
Primary	Comparison of Quantra Fibrinogen Contribution to Clot Stiffness test results to laboratory fibrinogen	Coagulation function assessed by Quantra and laboratory fibrinogen testing	Prior to surgery (Baseline)
Primary	Comparison of Quantra Fibrinogen Contribution to Clot Stiffness test results to laboratory fibrinogen	Coagulation function assessed by Quantra and laboratory fibrinogen testing	Post-bypass (10 to 20 minutes after protamine administration).
Primary	Comparison of Quantra Platelet Contribution to Clot Stiffness test results to laboratory platelet count	Coagulation function assessed by Quantra and laboratory fibrinogen testing	Post-bypass (10 to 20 minutes after protamine administration).
Primary	Comparison of Quantra Platelet Contribution to Clot Stiffness test results to laboratory platelet count	Coagulation function assessed by Quantra and platelet count	Prior to surgery (Baseline)