QStat in Trauma and Obstetric Hemorrhage
Completed
Conditions studied: Blood Loss Massive, Trauma, Post Partum Hemorrhage
In brief
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.
Key facts
- Study ID
- NCT04385953
- Run by
- HemoSonics LLC
- People needed
- 22
- Starts
- 2019-12-10
- Expected to finish
- 2020-08-01
- Last updated by the study team
- 2020-09-01
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Zuckerberg San Francisco General Hospital and Trauma Center — San Francisco, California, United States
Full record on ClinicalTrials.gov
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