Evaluation of the Clinical Performance of the Quantra System With the QStat Cartridge

Completed

Conditions studied: Blood Loss Massive, Trauma, Hemorrhage, Postpartum

In brief

This pilot study will evaluate the performance of the Quantra System comprised of the Quantra Hemostasis Analyzer with the QStat Cartridge in trauma patients or patients with OB hemorrhage.

Key facts

Study ID

NCT03912545

Run by

HemoSonics LLC

People needed

30

Starts

2019-03-04

Expected to finish

2019-07-11

Last updated by the study team

2019-10-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject is ≥ 18 years of age
• Subject has one of the following conditions and is a candidate for a ROTEM test to be performed to access coagulopathy: trauma patient; patient with OB hemorrhage.
• For trauma patients; 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.
• For subjects experiencing OB hemorrhage, one of the following conditions must be met (to be confirmed):
• Estimated blood loss during vaginal delivery is greater than 1000 mL
• Estimated blood loss during cesarean delivery is greater than 1500 mL
• Placental abruption with hemorrhage of any quantity blood loss
• Clinically suspected disseminated intravascular coagulation (DIC)
• Is under consideration for administration of tranexamic acid (TXA) for treatment of hemorrhage.
• Subject is willing to participate, and is willing to consent (either prospectively or by deferred consent)

You may not qualify if…

• Subject is younger than 18 years of age
• Subject is known to have received antifibrinolytic therapy immediately prior to presentation to trauma unit or during labor just prior to OB hemorrhage.
• 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.

Where it is running

• Texas Tech University Health Sciences Center El Paso — El Paso, Texas, United States

Full record on ClinicalTrials.gov

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