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 range

18 Years – 50 Years

Sex

FEMALE

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

View on ClinicalTrials.gov More Blood Loss Massive trials