Evaluation of the Quantra QStat System in Obstetric Patients

Post Operative Hemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05875987
• Other study ID #: HEMCS-044
• Status: Completed
• Start date: June 1, 2023
• Est. completion date: May 10, 2024

Study information

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

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 10, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blood Loss Massive
• Blood Loss, Surgical
• Hemorrhage
• Post Operative Hemorrhage
• Postoperative Hemorrhage

Intervention

Device:
• Quantra System
Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care.

Locations

Country	Name	City	State
United States	Duke University Hospital	Durham	North Carolina

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