Evaluation of the Clinical Performance of the Quantra System With the QStat Cartridge in Trauma and Liver Transplantation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- HemoSonics LLC
- Enrollment
- 397
- Locations
- 10
- Primary Endpoint
- Comparison of Quantra Clot Stiffness (CS) to ROTEM Delta EXTEM A20 results
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Comparison of Quantra Clot Stiffness (CS) to ROTEM Delta EXTEM A20 results
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: During post-reperfusion phase of liver transplant surgery
Coagulation function assessed by Quantra and ROTEM Delta
Secondary Outcomes
No secondary outcomes reported