NCT04301193

Evaluation of Novel Point of Care Coagulation System in Pregnant Women

Efficacy of Sonorheometry Point of the Care Device in Determining Low Fibrinogen Levels in Pregnant Blood: an Invitro Dilution and Reconstitution Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 13 (actual)
• Sponsor: University of Maryland, Baltimore · Academic / Other
• Sex: Female
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

In this study the investigators will evaluate a new point of care Quantra Hemostasis Analyzer system to assess coagulation rapidly with ease.

Detailed description

Unexpected bleeding continues to be an issue that confronts anesthesiologists. Obstetric bleeding spearheads as the leading cause of maternal mortality and morbidity. One of the hurdles that clinicians confront is a lack of point of care coagulation system that can hasten the clinical management strategy in the right direction. Conventional methods take considerable time to obtain results. TEG and ROTEM are currently doing the job however these two modalities requires expertise and proficient training to perform test and interpret results. The level of expertise to run the TEG and ROTEM poses hurdles for providing coagulation around the clock as it requires trained operators. What is currently required for efficient and effective management of obstetric hemorrhage is a point of care coagulation system in the operating room and or labor and delivery suite that is user friendly, easy and quick to perform. In this study the investigators will evaluate a new point of care Quantra Hemostasis Analyzer system to assess coagulation rapidly with ease.

Conditions

• Hemorrhage
• Coagulation Delay

Interventions

Type	Name	Description
DEVICE	Quantra Analyzer	Subject's blood samples will be manipulated in the lab and will be tested with the Quantra Analyzer. After obtaining blood from each patient, the blood was diluted to varying dilutions to obtain different fibrinogen concentrations. This way, 89 samples were prepared from the blood from 13 patients. Each sample was analyzed for fibrinogen concentration in the lab using conventional technology. Additionally each sample was used to measure Quantra variables such as clot stiffness (CS), and fibrinogen contribution to clot stiffness (FCS).

Timeline

• Start date: 2019-11-01
• Primary completion: 2020-07-31
• Completion: 2020-07-31
• First posted: 2020-03-10
• Last updated: 2025-04-27
• Results posted: 2025-04-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study