CompletedNot Applicable

QStat in Trauma and Obstetric Hemorrhage

United States22 participantsStarted 2019-12-10

Plain-language 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 hemorrhage.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓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.

What they're measuring

Comparison of the Quantra results to corresponding ROTEM Delta results

Timeframe: Upon arrival to emergency department

Comparison of the Quantra results to corresponding ROTEM Delta results

Timeframe: At the time of hemorrhage for obstetric patients

Trial details

NCT IDNCT04385953

SponsorHemoSonics LLC

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2020-07-01

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