QStat Cartridge in Obstetric Patients

Evaluation of the Clinical Performance of the Quantra® System With the QStat® Cartridge in Obstetric Patients

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.

Study Overview

• Status: Completed
• Conditions: Post Partum Hemorrhage; Blood Loss Massive
• Intervention / Treatment: Diagnostic test: Quantra Hemostasis Analyzer with the QStat Cartridge

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 296

Contacts and Locations

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14642
      • University of Rochester Medical Center
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University Wexner Medical Center
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • University of Oklahoma Medical Center
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Magee Womens Hospital
  • Texas
    • Dallas, Texas, United States, 75235
      • Parkland Health
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • University of Utah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Parturients 18 years or older who are at risk of experiencing an obstetric hemorrhage around the time of delivery.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Obstetric Patients; Obstetric patient population at risk of experiencing excessive bleeding around the time of delivery	Diagnostic test: Quantra Hemostasis Analyzer with the QStat Cartridge; Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care.; Other Names: QStat Cartridge; Quantra System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of Quantra Clot Time to laboratory aPTT test results	Coagulation function assessed by Quantra Clot Time (CT, sec) and activated partial thromboplastin (aPTT, sec) test	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	Coagulation function assessed by Quantra Fibrinogen Contribution to Clot Stiffness (FCS, hPa) and Clauss fibrinogen (mg/dL) test	At the time hemorrhage is suspected, anticipated within 24 hours after birth
Comparison of Quantra Clot Time to ROTEM delta INTEM CT test results	Coagulation function assessed by Quantra Clot Time (CT, sec) and ROTEM INTEM CT (sec) test	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	Coagulation function assessed by Quantra Fibrinogen Contribution to Clot Stiffness (FCS, hPa) and ROTEM FIBTEM (mm) test	At the time hemorrhage is suspected, anticipated within 24 hours after birth

Collaborators and Investigators

• Sponsor: HemoSonics LLC

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2024
• Primary Completion (Actual): August 15, 2025
• Study Completion (Actual): October 30, 2025

Study Registration Dates

• First Submitted: February 4, 2024
• First Submitted That Met QC Criteria: February 4, 2024
• First Posted (Actual): February 13, 2024

Study Record Updates

• Last Update Posted (Estimated): November 14, 2025
• Last Update Submitted That Met QC Criteria: November 13, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Coagulation; Quantra; Viscoelastic testing
• Additional Relevant MeSH Terms: Urogenital Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor Complications; Pregnancy Complications; Hemorrhage; Embolism and Thrombosis; Puerperal Disorders; Uterine Hemorrhage; Pathological Conditions, Signs and Symptoms; Thrombosis; Postpartum Hemorrhage; Coagulants; Hemostatics
• Other Study ID Numbers: HEMCS-048

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes