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

Inclusion Criteria

• •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)