Trauma Clinical Trial
Official title:
Evaluation of the Clinical Performance of the Quantra System With the QStat Cartridge in Trauma and Obstetric Hemorrhage
NCT number | NCT04385953 |
Other study ID # | HEMCS-030 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | December 10, 2019 |
Est. completion date | August 1, 2020 |
Verified date | August 2020 |
Source | HemoSonics LLC |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This study will evaluate the performance of the Quantra System comprised of the Quantra Hemostasis Analyzer with the QStat Cartridge in trauma patients and obstetric patients with postpartum hemorrhage.
Status | Completed |
Enrollment | 22 |
Est. completion date | August 1, 2020 |
Est. primary completion date | July 1, 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 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.and is a candidate for a ROTEM test to be performed to access coagulopathy. OR -Subject is an obstetric patient experiencing post-partum hemorrhage based on one of the following conditions: estimated blood loss during delivery >1000 mL; placental abruption with hemorrhage of any quantity; clinically suspected DIC; pregnancy resulted in fetal demise with hemorrhage of any quantity; or is under consideration for administration of tranexamic acid for treatment of hemorrhage. Exclusion Criteria: - Subject is younger than 18 years of age - Subject presents for a procedure intended to abort a pregnancy for reasons other than medical necessity - Subject is known to have received antifibrinolytic therapy immediately prior to presentation to trauma unit - 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 | Zuckerberg San Francisco General Hospital and Trauma Center | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
HemoSonics LLC |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Comparison of the Quantra results to corresponding ROTEM Delta results | Coagulation function assessed by Quantra and ROTEM delta | Upon arrival to emergency department | |
Primary | Comparison of the Quantra results to corresponding ROTEM Delta results | Coagulation function assessed by Quantra and ROTEM delta | At the time of hemorrhage for obstetric patients |
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