Evaluation of Novel Point of Care Coagulation System in Pregnant Women (CCPW)

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

Study Overview

• Status: Completed
• Conditions: Hemorrhage; Coagulation Delay
• Intervention / Treatment: Device: Quantra Analyzer

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.

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland Baltimore

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Pregnant woman at 37-41 weeks gestation

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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; Subjects blood will be manipulated in the lab and will be tested with the Quantra Analyzer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of coagulation using Quantra system.	How Fibrinogen level of the patient is reflected by FCS (Fibrinogen Clot Strength of Quantra)	Baseline
Determine how other conventional tests such as PT, PTT, and INR relate to clotting time of Quantra.	How PT, PTT, and INR level of the patient is reflected by Clot Strength of Quantra	Baseline

Collaborators and Investigators

• Sponsor: University of Maryland, Baltimore
• Collaborators: HemoSonics LLC
• Investigators: Principal Investigator: Bhavani Kodali, MD, University of Maryland, Baltimore

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2019
• Primary Completion (Actual): July 31, 2020
• Study Completion (Actual): July 31, 2020

Study Registration Dates

• First Submitted: February 26, 2020
• First Submitted That Met QC Criteria: March 5, 2020
• First Posted (Actual): March 10, 2020

Study Record Updates

• Last Update Posted (Actual): May 7, 2021
• Last Update Submitted That Met QC Criteria: May 6, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage
• Other Study ID Numbers: 84317

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes