Evaluation of the Clinical Performance of the Quantra System With the QStat Cartridge in Trauma and Liver Transplantation
Status: Completed
Location: See all (10) locations...
Intervention Type: Diagnostic test
Study Type: Observational
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
View:
• 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.
Locations
United States
California
Zuckerberg San Francisco General Hospital and Trauma Center
San Francisco
Colorado
University of Colorado
Denver
Florida
University of Florida Health Shands Hospital
Gainesville
Michigan
University of Michigan Medical Center
Ann Arbor
Ohio
Ohio State University
Columbus
Oklahoma
University of Oklahoma Medical Center
Oklahoma City
South Carolina
Spartanburg Regional Medical Center
Spartanburg
Texas
University of Texas Southwestern Medical Center
Dallas
Texas Tech University Health Sciences Center
El Paso
Virginia
University of Virginia Medical Center
Charlottesville
Time Frame
Start Date: 2020-07-20
Completion Date: 2023-04-13
Participants
Target number of participants: 397
Treatments
Trauma patients
Trauma patients experiencing traumatic injuries requiring a full trauma team response.
Liver transplant patients
Patients undergoing liver transplant surgery.
Authors
Related Therapeutic Areas
Sponsors
Leads: HemoSonics LLC