CompletedNot Applicable

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

United States30 participantsStarted 2019-03-04

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

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 ≥ 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) Exclusion Criteria: * 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 …

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 and Clot Stiffness results to standard coagulation test results

Timeframe: Upon arrival to emergency department (trauma subjects) or upon presentation with obstetric hemorrhage, prior to the administration of blood products or antifibrinolytics in parallel with samples collected for routine ROTEM analysis and laboratory assays

Comparison of Quantra Clot Time and Clot Stiffness results to ROTEM Delta results

Timeframe: Upon arrival to emergency department (trauma subjects) or upon presentation with OB hemorrhage, prior to the administration of blood products or antifibrinolytics in parallel with samples collected for routine ROTEM analysis and laboratory assays

Comparison of Quantra Fibrinolysis results to ROTEM Delta results

Trial details

NCT IDNCT03912545

SponsorHemoSonics LLC

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2019-07-11

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