HemoSonics - UTMB Cardiac Surgery Study

Blood Loss, Surgical Clinical Trial

Official title:

HemoSonics - UTMB Cardiac Surgery Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03988465
• Other study ID #: HEMCS-024
• Status: Completed
• Start date: June 19, 2019
• Est. completion date: May 15, 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 Quantra QPlus Cartridge in patients undergoing cardiac surgery utilizing cardiopulmonary bypass, including the placement of a ventricular access device.

Description:

The Quantra System is a fully integrated and automated in vitro diagnostic device which uses SEER Sonorheometry, and 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-center, prospective, observational study will evaluate the performance of the Quantra System as compared to and comparable measures determined using the TEG 5000.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 15, 2020
• Est. primary completion date: March 13, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subject is = 18 years

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

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

Exclusion Criteria:

• Subject is younger than 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	University of Texas Medical Branch	Galveston	Texas

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 results to TEG R results	Coagulation function assessed by Quantra and TEG 5000	Baseline, defined as after induction of anesthesia but before surgical incision
Primary	Comparison of Quantra Clot Stiffness results to TEG MA results	Coagulation function assessed by Quantra and TEG 5000	Baseline, defined as after induction of anesthesia but before surgical incision
Primary	Comparison of Quantra Clot Time results to TEG R results	Coagulation function assessed by Quantra and TEG 5000	During bypass
Primary	Comparison of Quantra Clot Stiffness results to TEG MA results	Coagulation function assessed by Quantra and TEG 5000	During bypass
Primary	Comparison of Quantra Clot Time results to TEG R results	Coagulation function assessed by Quantra and TEG 5000	Post-bypass, defined as 10 to 20 minutes after protamine administration
Primary	Comparison of Quantra Clot Stiffness results to TEG MA results	Coagulation function assessed by Quantra and TEG 5000	Post-bypass, defined as 10 to 20 minutes after protamine administration
Primary	Comparison of Quantra Clot Time results to standard coagulation test results (aPTT)	Coagulation function assessed by Quantra and standard coagulation tests	Baseline, defined as after induction of anesthesia but before surgical incision
Primary	Comparison of Quantra Clot Stiffness results to laboratory fibrinogen results	Coagulation function assessed by Quantra and standard coagulation tests	Baseline, defined as after induction of anesthesia but before surgical incision
Primary	Comparison of Quantra Clot Stiffness results to laboratory-determined platelet count	Coagulation function assessed by Quantra and standard coagulation tests	Baseline, defined as after induction of anesthesia but before surgical incision
Primary	Comparison of Quantra Clot Time results to standard coagulation test results (aPTT)	Coagulation function assessed by Quantra and standard coagulation tests	During bypass
Primary	Comparison of Quantra Clot Stiffness results to laboratory fibrinogen results	Coagulation function assessed by Quantra and standard coagulation tests	During bypass
Primary	Comparison of Quantra Clot Stiffness results to laboratory-determined platelet count	Coagulation function assessed by Quantra and standard coagulation tests	During bypass
Primary	Comparison of Quantra Clot Time results to standard coagulation test results (aPTT)	Coagulation function assessed by Quantra and standard coagulation tests	Post-bypass, defined as 10 to 20 minutes after protamine administration
Primary	Comparison of Quantra Clot Stiffness results to laboratory fibrinogen results	Coagulation function assessed by Quantra and standard coagulation tests	Post-bypass, 10 to 20 minutes after protamine
Primary	Comparison of Quantra Clot Stiffness results to laboratory-determined platelet count	Coagulation function assessed by Quantra and standard coagulation tests	Post-bypass, defined as 10 to 20 minutes after protamine administration