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Evaluation of Novel Point of Care Coagulation System in Pregnant Women

NCT04301193 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 13

Last updated 2025-04-27

Study results available
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Summary

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

Conditions

Interventions

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).

Sponsors & Collaborators

  • HemoSonics LLC

    collaborator INDUSTRY

  • University of Maryland, Baltimore

    lead OTHER

Principal Investigators

  • Bhavani Kodali, MD · University of Maryland, Baltimore

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-11-01
Primary Completion
2020-07-31
Completion
2020-07-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04301193 on ClinicalTrials.gov