QStat Cartridge in Obstetric Patients | Clinical Trial

Key information

Conditions

Blood Loss Massive Cardiovascular Diseases Embolism and Thrombosis Female Urogenital Diseases and Pregnancy Complications Hemorrhage Obstetric Labor Complications Pathologic Processes Pathological Conditions, Signs and Symptoms Post Partum Hemorrhage Postpartum Hemorrhage Pregnancy Complications Puerperal Disorders Thrombosis Urogenital Diseases Uterine Hemorrhage Vascular Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

University of Rochester Medical Center, Rochester, New York, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Quantra Hemostasis Analyzer with the QStat Cartridge

Diagnostic Test

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

Other names: Quantra System, QStat Cartridge

Primary outcomes

Comparison of Quantra Clot Time to laboratory aPTT test results

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

Coagulation function assessed by Quantra Clot Time (CT, sec) and activated partial thromboplastin (aPTT, sec) test
Comparison of Quantra Fibrinogen Contribution to Clot Stiffness to laboratory coagulation fibrinogen test results

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

Coagulation function assessed by Quantra Fibrinogen Contribution to Clot Stiffness (FCS, hPa) and Clauss fibrinogen (mg/dL) test
Comparison of Quantra Clot Time to ROTEM delta INTEM CT test results

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

Coagulation function assessed by Quantra Clot Time (CT, sec) and ROTEM INTEM CT (sec) test
Comparison of Quantra Fibrinogen Contribution to Clot Stiffness to ROTEM delta FIBTEM test results

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

Coagulation function assessed by Quantra Fibrinogen Contribution to Clot Stiffness (FCS, hPa) and ROTEM FIBTEM (mm) test

Sponsors and collaborators

Lead sponsor

HemoSonics LLC

Industry

Registry information

Official study title

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

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Feb 13, 2024
Registry last updated: Nov 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed