QStat Cartridge in Obstetric Patients

Post Partum Hemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06255496
• Other study ID #: HEMCS-048
• Status: Enrolling by invitation
• Start date: May 9, 2024
• Est. completion date: January 31, 2025

Study information

• Verified date: May 2024
• Source: HemoSonics LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 300
• Est. completion date: January 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Blood Loss Massive
• Hemorrhage
• Post Partum Hemorrhage
• Postpartum Hemorrhage

Intervention

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.

Locations

Country	Name	City	State
United States	Ohio State University Wexner Medical Center	Columbus	Ohio
United States	University of Oklahoma Medical Center	Oklahoma City	Oklahoma
United States	University of Utah	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
HemoSonics LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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