Quantra QStat in Trauma and Liver Transplant
- Conditions
- HemorrhageLiver TransplantTrauma
- Registration Number
- NCT04312958
- Lead Sponsor
- HemoSonics LLC
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 397
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Comparison of Quantra Clot Stiffness (CS) to ROTEM Delta EXTEM A20 results During post-reperfusion phase of liver transplant surgery Coagulation function assessed by Quantra and ROTEM Delta
Comparison of Quantra Clot Stability to Lysis (CSL) to ROTEM Delta EXTEM ML results During post-reperfusion phase of liver transplant surgery Coagulation function assessed by Quantra and ROTEM Delta
Comparison of Quantra Clot Time (CT) to ROTEM Delta INTEM CT results During post-reperfusion phase of liver transplant surgery Coagulation function assessed by Quantra and ROTEM Delta
Comparison of Quantra Fibrinogen Contribution (FCS) to ROTEM Delta FIBTEM A20 results During post-reperfusion phase of liver transplant surgery Coagulation function assessed by Quantra and ROTEM Delta
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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Trial Locations
- Locations (10)
Zuckerberg San Francisco General Hospital and Trauma Center
🇺🇸San Francisco, California, United States
University of Colorado
🇺🇸Denver, Colorado, United States
University of Florida Health Shands Hospital
🇺🇸Gainesville, Florida, United States
University of Michigan Medical Center
🇺🇸Ann Arbor, Michigan, United States
Ohio State University
🇺🇸Columbus, Ohio, United States
University of Oklahoma Medical Center
🇺🇸Oklahoma City, Oklahoma, United States
Spartanburg Regional Medical Center
🇺🇸Spartanburg, South Carolina, United States
University of Texas Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Texas Tech University Health Sciences Center
🇺🇸El Paso, Texas, United States
University of Virginia Medical Center
🇺🇸Charlottesville, Virginia, United States
Zuckerberg San Francisco General Hospital and Trauma Center🇺🇸San Francisco, California, United States