Evaluation of the Quantra QStat System in Obstetric Patients

Pilot Study Evaluating the Clinical Performance of the Quantra With the QStat Cartridge at the Point-of-care in Obstetric Patients

This pilot study will assess the performance of the Quantra System with the QStat Cartridge versus standard of care coagulation testing in bleeding pregnant women at delivery.

Study Overview

• Status: Completed
• Conditions: Post Operative Hemorrhage; Blood Loss Massive
• Intervention / Treatment: Device: Quantra System

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 single-center, 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 bleeding pregnant women at delivery.

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Hospital

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Pparturients 18 years or older who experience an obstetric hemorrhage around the time of delivery or cumulatively over 24h after delivery or unstable vital signs or clinical signs of a coagulopathy managed with activation of the stage 2 OB hemorrhage protocol.

Description

Inclusion Criteria:

• Subject is > 18 years.
• Subject is pregnant or at least 24 h postpartum
• Subject is fluent in English language.
• Subject is experiencing significant bleeding resulting in activation of the stage 2 OB hemorrhage protocol as defined by blood loss ≥1500ml at delivery or within the first 24 hours after delivery, and/or is hemodynamically unstable and/or is experiencing increased abnormal bleeding not responsive to OB stage 1 hemorrhage resuscitation.
• Subject or subject's legally authorized representative (LAR) is willing to provide informed consent, either prospectively or by deferred consent.

Exclusion Criteria:

• 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 experiencing excessive bleeding around the time of delivery	Device: Quantra System; Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care.; Other Names: QStat Cartridge

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 the OB hemorrhage protocol is activated, anticipated with 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 the OB hemorrhage protocol is activated, anticipated with 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 the OB hemorrhage protocol is activated, anticipated with 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 the OB hemorrhage protocol is activated, anticipated with 24 hours after birth

Collaborators and Investigators

• Sponsor: HemoSonics LLC

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Actual): March 31, 2024
• Study Completion (Actual): May 10, 2024

Study Registration Dates

• First Submitted: April 28, 2023
• First Submitted That Met QC Criteria: May 19, 2023
• First Posted (Actual): May 25, 2023

Study Record Updates

• Last Update Posted (Actual): May 13, 2024
• Last Update Submitted That Met QC Criteria: May 10, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Coagulation; Quantra; Viscoelastic testing
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Intraoperative Complications; Hemorrhage; Blood Loss, Surgical; Postoperative Hemorrhage
• Other Study ID Numbers: HEMCS-044

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