Trauma Clinical Trial
Official title:
Evaluation of the Clinical Performance of the Quantra System With the QStat Cartridge in Trauma
NCT number | NCT03934983 |
Other study ID # | HEMCS-021 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 28, 2019 |
Est. completion date | January 31, 2020 |
Verified date | February 2020 |
Source | HemoSonics LLC |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This pilot study will evaluate the performance of the Quantra System comprised of the Quantra Hemostasis Analyzer with the QStat Cartridge in trauma patients.
Status | Completed |
Enrollment | 30 |
Est. completion date | January 31, 2020 |
Est. primary completion date | January 29, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Subject is = 18 years of age - Subject is a trauma patient and is a candidate for a ROTEM test to be performed to access coagulopathy - Subject must be experiencing major trauma (preferably requiring the highest level of team activation) with active bleeding or deemed at high risk of significant bleeding according to mechanism of injury. - Subject is willing to participate, and is willing to consent (either prospectively or by deferred consent) Exclusion Criteria: - Subject is younger than 18 years of age - Subject weighs less than 110 pounds - Subject is known to have received antifibrinolytic therapy immediately prior to presentation to trauma unit - Subject is unable to provide written informed consent (either prior to performing any study related procedures or by deferred consent) - Subject is currently enrolled in a distinct study that might confound the results of the proposed study - Subject is affected by a condition that, in the opinion of the clinical team, may pose additional risks. |
Country | Name | City | State |
---|---|---|---|
United States | University of Texas Southwestern Medical Center | Dallas | Texas |
Lead Sponsor | Collaborator |
---|---|
HemoSonics LLC |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Comparison of the Quantra Clot Time results to standard coagulation test results | Coagulation function assessed by Quantra and standard coagulation tests | Upon arrival to emergency department | |
Primary | Comparison of the Quantra Clot Stiffness results to standard coagulation test results | Coagulation function assessed by Quantra and standard coagulation tests | Upon arrival to emergency department | |
Primary | Comparison of the Quantra Clot Time results to ROTEM Delta results | Coagulation function assessed by Quantra and ROTEM delta | Upon arrival to emergency department | |
Primary | Comparison of the Quantra Clot Stiffness results to ROTEM Delta results | Coagulation function assessed by Quantra and ROTEM delta | Upon arrival to emergency department | |
Primary | Comparison of the Quantra Fibrinolysis results to ROTEM Delta results | Coagulation function assessed by Quantra and ROTEM delta | Upon arrival to emergency department |
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