Evaluation of Novel Point of Care Coagulation System in Pregnant Women

NCT04301193 | Completed Results FDA Device

• 1 other identifier: 84317
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

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

Outcome Measures

Primary Outcomes (2)

• Correlation of Fibrinogen in mg/dL Concentration With Clot Strength (CS hPa) and Fibrinogen Contribution to Clot (FCS hPa) of Point of the Care Quantra System.

  The Fibrinogen level of the patient in mg/dL is reflected by CS (clost strength measured in hPa) and FCS (Fibrinogen Contribution for Clot Stiffness measured by Quantra measured in hPa). CS and FCS are Quantra measurements of blood clot strength. The higher the CS and FCS, the stronger the clot and the higher the fibrinogen in the blood. Whole blood samples from pregnant women were diluted with saline to obtain various levels of fibrinogen. The diluted samples were reconstituted with plasma to obtain varying concentrations of fibrinogen. Each sample of the diluted and reconstituted blood was analyzed in the laboratory for fibrinogen level, as well as CS and FCS, using the Qunatra Point of Care system. The correlation between fibrinogen levels and respective CS and FCS was studied. The accuracy of FCS in determining low fibrinogen was the goal of the study. In all 89 samples were obtained from blood obtained from 13 participants.

  Baseline: This is invitro study of the blood obtained from pregnant women (base line). This is a non-interventional observational study. Baseline samples were diluted and reconstituted and were analyzed on the same day within 4 hours of preparation.

• Correlation of Fibrinogen in mg/dL Concentration With Clot Strength (CS hPa) and Fibrinogen Contribution to Clot (FCS hPa) of Point of the Care Quantra System.

  The Fibrinogen level of the patient in mg/dL is reflected by CS (clot strength measured in hPa) and FCS (Fibrinogen Contribution for Clot Stiffness measured by Quantra measured in hPa). CS and FCS are Quantra measurements of blood clot strength. The higher the CS and FCS, the stronger the clot and the higher the fibrinogen in the blood. Whole blood samples from pregnant women were diluted with saline to obtain various levels of fibrinogen. The diluted samples were reconstituted with plasma to obtain varying concentrations of fibrinogen. Each sample of the diluted and reconstituted blood was analyzed in the laboratory for fibrinogen level, as well as CS and FCS, using the Qunatra Point of Care system. The correlation between fibrinogen levels and respective CS and FCS was studied. The accuracy of FCS in determining low fibrinogen was the goal of the study. In all 89 samples were obtained from blood obtained from 13 participants.

  Baseline: This is invitro study of the blood obtained from pregnant women (base line). This is a non-interventional observational study. Baseline samples were diluted and reconstituted and were analyzed on the same day

Study Arms (1)

Pregnant Women

All subjects will have the same intervention. Samples will be taken and manipulated in the laboratory for use of the Hemosonic Qauntra Analyzer

Device: Quantra Analyzer

Interventions

Quantra Analyzer DEVICE

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).

Pregnant Women

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women

You may qualify if:

• Pregnant woman at 37-41 weeks gestation

You may not qualify if:

• Hypertension
• Preeclampsia
• Gestational diabetes
• Preexisting coagulopathy
• History of deep vein thrombosis (DVT)
• Medications that impair coagulation
• History of pulmonary embolism or thrombosis
• Women in active labor receiving intravenous fluids or oxytocin

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• HemoSonics LLC: collaborator

Study Sites (1)

University of Maryland Baltimore

Baltimore, Maryland, 21201, United States

Location

Related Publications (1)

• Kodali BS, Karuppiah A, Bharadwaj S, Chow J, Tanaka K. Efficacy of sonorheometry point of the care device in determining low fibrinogen levels in pregnant blood: an invitro dilution and reconstitution study. J Clin Monit Comput. 2022 Oct;36(5):1423-1431. doi: 10.1007/s10877-021-00782-1. Epub 2021 Dec 3.

  PMID: 34859304 RESULT

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Division Chief of Obstetric Anesthesiology
• Organization: University of Maryland

bkodali@som.umaryland.edu

(410) 328-4229

Study Officials

• Bhavani Kodali, MD

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: February 26, 2020
• First Posted: March 10, 2020
• Study Start: November 1, 2019
• Primary Completion: July 31, 2020
• Study Completion: July 31, 2020
• Last Updated: April 27, 2025
• Results First Posted: April 27, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)