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QStat Cartridge in Obstetric Patients

NCT ID: NCT06255496

Last Updated: 2025-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

296 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-09

Study Completion Date

2025-10-30

Brief Summary

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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.

Detailed Description

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The Quantra System is a fully integrated and automated in vitro diagnostic device which uses SEER Sonorheometry, an ultrasound-based technology, to characterize the viscoelastic properties of a whole blood sample during coagulation. The QStat Cartridge was developed to monitor hemostasis in patients that may experience a range of coagulopathies of various etiologies including fibrinolytic defects. These patients include the tobstetric hemorrhage population. The cartridge consists of four independent channels each containing different sets of reagents, which provide four measurements performed in parallel yielding five parameters that depict the functional status of a patient's coagulation system.

This multicenter, prospective, observational pilot study will evaluate the performance of the Quantra System with the QStat Cartridge as compared to standard of care coagulation testing in pregnant women at risk of bleeding at delivery.

Conditions

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Blood Loss Massive Post Partum Hemorrhage

Keywords

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Quantra Viscoelastic testing Coagulation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Obstetric Patients

Obstetric patient population at risk of experiencing excessive bleeding around the time of delivery

Quantra Hemostasis Analyzer with the QStat Cartridge

Intervention Type DIAGNOSTIC_TEST

Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care.

Interventions

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Quantra Hemostasis Analyzer with the QStat Cartridge

Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Quantra System QStat Cartridge

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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HemoSonics LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Rochester Medical Center

Rochester, New York, United States

Site Status

Ohio State University Wexner Medical Center

Columbus, Ohio, United States

Site Status

University of Oklahoma Medical Center

Oklahoma City, Oklahoma, United States

Site Status

Magee Womens Hospital

Pittsburgh, Pennsylvania, United States

Site Status

Parkland Health

Dallas, Texas, United States

Site Status

University of Utah

Salt Lake City, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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HEMCS-048

Identifier Type: -

Identifier Source: org_study_id