CompletedNot Applicable

QStat Cartridge in Obstetric Patients

United States296 participantsStarted 2024-05-09

Plain-language summary

This study will assess the performance of the Quantra System with the QStat Cartridge versus standard of care coagulation testing in pregnant women at risk of bleeding at delivery.

Who can participate

Age range18 Years – 50 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Subject is greater than18 years. * Subject is pregnant or at least 24 h postpartum * Conventional coagulation tests and/or viscoelastic testing are ordered for concern of possible coagulopathy based on one or more clinical scenarios including hemorrhage, suspected or confirmed placental abruption, amniotic fluid embolism, or placenta accreta spectrum * Subject or subject's LAR is willing to provide informed consent, either prospectively or by deferred consent. Exclusion Criteria: * Subject is younger than 18 years old. * Subject or subject's LAR is unwilling or unable to provide informed consent, either prospectively or by deferred consent. * Subject is incarcerated at the time of the study. * 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

What they're measuring

Comparison of Quantra Clot Time to laboratory aPTT test results

Timeframe: At the time hemorrhage is suspected, anticipated within 24 hours after birth

Comparison of Quantra Fibrinogen Contribution to Clot Stiffness to laboratory coagulation fibrinogen test results

Timeframe: At the time hemorrhage is suspected, anticipated within 24 hours after birth

Comparison of Quantra Clot Time to ROTEM delta INTEM CT test results

Timeframe: At the time hemorrhage is suspected, anticipated within 24 hours after birth

Comparison of Quantra Fibrinogen Contribution to Clot Stiffness to ROTEM delta FIBTEM test results

Timeframe: At the time hemorrhage is suspected, anticipated within 24 hours after birth

Trial details

NCT IDNCT06255496

SponsorHemoSonics LLC

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-08-15

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