Quantra QStat in Trauma and Liver Transplant

Trauma Clinical Trial

Official title:

Evaluation of the Clinical Performance of the Quantra System With the QStat Cartridge in Trauma and Liver Transplantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04312958
• Other study ID #: HEMCS-032
• Status: Completed
• Start date: July 20, 2020
• Est. completion date: April 13, 2023

Study information

• Verified date: April 2023
• Source: HemoSonics LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a multi-center prospective, observational study of the Quantra System with the QStat Cartridge in trauma patients and patients undergoing liver transplant.

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 QStat Cartridge was developed to monitor hemostasis in patients that may experience a range of coagulopathies of various etiologies, including fibrinolytic defects. These patients include the trauma and liver transplant populations. The cartridge consists of four independent channels each containing different sets of reagents, which provide four measurements performed in parallel yielding five parameters that depict the functional status of a patient's coagulation system. This multi-center, prospective, observational pilot study will evaluate the performance of the Quantra System with the QStat Cartridge as compared to conventional viscoelastic testing methods in blood samples obtained from trauma patients and patients undergoing liver transplant.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 397
• Est. completion date: April 13, 2023
• Est. primary completion date: December 31, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subject is > 18 years
• Subject is a trauma patient experiencing traumatic injuries requiring a full trauma team response OR Subject is a patient undergoing liver transplant surgery.
• Subject, or subject's legally authorized representative (LAR), is willing to provide informed consent, either prospectively or by deferred consent, OR Institutional Review Board (IRB)/Ethics Committee (EC) has waived the requirement to obtain informed consent.

Exclusion Criteria:

• Subject is younger than 18 years of age
• Subject is pregnant.
• Subject is incarcerated at the time of the study.
• Subject is currently enrolled in a distinct study that might confound the result of the proposed study
• Subject is affected by a condition that, in the opinion of the surgical team, may pose additional risks.

Related Conditions & MeSH terms

• Hemorrhage
• Liver Transplant
• Trauma
• Wounds and Injuries

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 Michigan Medical Center	Ann Arbor	Michigan
United States	University of Virginia Medical Center	Charlottesville	Virginia
United States	Ohio State University	Columbus	Ohio
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	University of Colorado	Denver	Colorado
United States	Texas Tech University Health Sciences Center	El Paso	Texas
United States	University of Florida Health Shands Hospital	Gainesville	Florida
United States	University of Oklahoma Medical Center	Oklahoma City	Oklahoma
United States	Zuckerberg San Francisco General Hospital and Trauma Center	San Francisco	California
United States	Spartanburg Regional Medical Center	Spartanburg	South Carolina

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 (CT) to ROTEM Delta INTEM CT results	Coagulation function assessed by Quantra and ROTEM Delta	Upon arrival of trauma subject to the emergency department
Primary	Comparison of Quantra Clot Time (CT) to ROTEM Delta INTEM CT results	Coagulation function assessed by Quantra and ROTEM Delta	Baseline, immediately before the start of liver transplant surgery
Primary	Comparison of Quantra Clot Time (CT) to ROTEM Delta INTEM CT results	Coagulation function assessed by Quantra and ROTEM Delta	During anhepatic phase of liver transplant surgery
Primary	Comparison of Quantra Clot Time (CT) to ROTEM Delta INTEM CT results	Coagulation function assessed by Quantra and ROTEM Delta	During post-reperfusion phase of liver transplant surgery
Primary	Comparison of Quantra Clot Stiffness (CS) to ROTEM Delta EXTEM A20 results	Coagulation function assessed by Quantra and ROTEM Delta	Upon arrival of trauma subject to the emergency department
Primary	Comparison of Quantra Clot Stiffness (CS) to ROTEM Delta EXTEM A20 results	Coagulation function assessed by Quantra and ROTEM Delta	Baseline, immediately before the start of liver transplant surgery
Primary	Comparison of Quantra Clot Stiffness (CS) to ROTEM Delta EXTEM A20 results	Coagulation function assessed by Quantra and ROTEM Delta	During anhepatic phase of liver transplant surgery
Primary	Comparison of Quantra Clot Stiffness (CS) to ROTEM Delta EXTEM A20 results	Coagulation function assessed by Quantra and ROTEM Delta	During post-reperfusion phase of liver transplant surgery
Primary	Comparison of Quantra Fibrinogen Contribution (FCS) to ROTEM Delta FIBTEM A20 results	Coagulation function assessed by Quantra and ROTEM Delta	Upon arrival of trauma subject to the emergency department
Primary	Comparison of Quantra Fibrinogen Contribution (FCS) to ROTEM Delta FIBTEM A20 results	Coagulation function assessed by Quantra and ROTEM Delta	Baseline, immediately before the start of liver transplant surgery
Primary	Comparison of Quantra Fibrinogen Contribution (FCS) to ROTEM Delta FIBTEM A20 results	Coagulation function assessed by Quantra and ROTEM Delta	During anhepatic phase of liver transplant surgery
Primary	Comparison of Quantra Fibrinogen Contribution (FCS) to ROTEM Delta FIBTEM A20 results	Coagulation function assessed by Quantra and ROTEM Delta	During post-reperfusion phase of liver transplant surgery
Primary	Comparison of Quantra Clot Stability to Lysis (CSL) to ROTEM Delta EXTEM ML results	Coagulation function assessed by Quantra and ROTEM Delta	Upon arrival of trauma subject to the emergency department
Primary	Comparison of Quantra Clot Stability to Lysis (CSL) to ROTEM Delta EXTEM ML results	Coagulation function assessed by Quantra and ROTEM Delta	Baseline, immediately before the start of liver transplant surgery
Primary	Comparison of Quantra Clot Stability to Lysis (CSL) to ROTEM Delta EXTEM ML results	Coagulation function assessed by Quantra and ROTEM Delta	During anhepatic phase of liver transplant surgery
Primary	Comparison of Quantra Clot Stability to Lysis (CSL) to ROTEM Delta EXTEM ML results	Coagulation function assessed by Quantra and ROTEM Delta	During post-reperfusion phase of liver transplant surgery