Clinical trial NCT04312958: Quantra QStat in Trauma and Liver Transplant
Official title: Evaluation of the Clinical Performance of the Quantra System With the QStat Cartridge in Trauma and Liver Transplantation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemorrhage
Trauma
Liver Transplant
Keywords: Viscoelastic testing
Coagulation
Trauma
Liver Transplant
Quantra
QStat
Lead sponsor: HemoSonics LLC
Sponsor class: INDUSTRY
First posted: 2020-03-18
Enrollment: 397
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Potential study participants will be adult (\>18 years) trauma patients or patients undergoing liver transplant surgery.

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Comparison of Quantra Clot Time (CT) to ROTEM Delta INTEM CT results
timeFrame: Upon arrival of trauma subject to the emergency department
measure: Comparison of Quantra Clot Time (CT) to ROTEM Delta INTEM CT results
timeFrame: Baseline, immediately before the start of liver transplant surgery
measure: Comparison of Quantra Clot Time (CT) to ROTEM Delta INTEM CT results
timeFrame: During anhepatic phase of liver transplant surgery
measure: Comparison of Quantra Clot Time (CT) to ROTEM Delta INTEM CT results
timeFrame: During post-reperfusion phase of liver transplant surgery
measure: Comparison of Quantra Clot Stiffness (CS) to ROTEM Delta EXTEM A20 results
timeFrame: Upon arrival of trauma subject to the emergency department
measure: Comparison of Quantra Clot Stiffness (CS) to ROTEM Delta EXTEM A20 results
timeFrame: Baseline, immediately before the start of liver transplant surgery
measure: Comparison of Quantra Clot Stiffness (CS) to ROTEM Delta EXTEM A20 results
timeFrame: During anhepatic phase of liver transplant surgery
measure: Comparison of Quantra Clot Stiffness (CS) to ROTEM Delta EXTEM A20 results
timeFrame: During post-reperfusion phase of liver transplant surgery
measure: Comparison of Quantra Fibrinogen Contribution (FCS) to ROTEM Delta FIBTEM A20 results
timeFrame: Upon arrival of trauma subject to the emergency department
measure: Comparison of Quantra Fibrinogen Contribution (FCS) to ROTEM Delta FIBTEM A20 results
timeFrame: Baseline, immediately before the start of liver transplant surgery
measure: Comparison of Quantra Fibrinogen Contribution (FCS) to ROTEM Delta FIBTEM A20 results
timeFrame: During anhepatic phase of liver transplant surgery
measure: Comparison of Quantra Fibrinogen Contribution (FCS) to ROTEM Delta FIBTEM A20 results
timeFrame: During post-reperfusion phase of liver transplant surgery
measure: Comparison of Quantra Clot Stability to Lysis (CSL) to ROTEM Delta EXTEM ML results
timeFrame: Upon arrival of trauma subject to the emergency department
measure: Comparison of Quantra Clot Stability to Lysis (CSL) to ROTEM Delta EXTEM ML results
timeFrame: Baseline, immediately before the start of liver transplant surgery
measure: Comparison of Quantra Clot Stability to Lysis (CSL) to ROTEM Delta EXTEM ML results
timeFrame: During anhepatic phase of liver transplant surgery
measure: Comparison of Quantra Clot Stability to Lysis (CSL) to ROTEM Delta EXTEM ML results
timeFrame: During post-reperfusion phase of liver transplant surgery
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Zuckerberg San Francisco General Hospital and Trauma Center
state: California
city: Denver
country: United States
facility: University of Colorado
state: Colorado
city: Gainesville
country: United States
facility: University of Florida Health Shands Hospital
state: Florida
city: Ann Arbor
country: United States
facility: University of Michigan Medical Center
state: Michigan
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma Medical Center
state: Oklahoma
city: Spartanburg
country: United States
facility: Spartanburg Regional Medical Center
state: South Carolina
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: El Paso
country: United States
facility: Texas Tech University Health Sciences Center
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia Medical Center
state: Virginia
Study officials:
References: