Status:
COMPLETED
QStat in Trauma and Obstetric Hemorrhage
Lead Sponsor:
HemoSonics LLC
Conditions:
Blood Loss Massive
Trauma
Eligibility:
All Genders
18+ years
Brief Summary
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 hemorrhag...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 10 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2020
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT04385953
Start Date
December 10 2019
End Date
August 1 2020
Last Update
September 1 2020
Active Locations (1)
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1
Zuckerberg San Francisco General Hospital and Trauma Center
San Francisco, California, United States, 941109