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

Primary Purpose

Hemorrhage, Coagulation Delay

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Quantra Analyzer
Sponsored by
University of Maryland, Baltimore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hemorrhage

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Maryland Baltimore

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Pregnant Women

Arm Description

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

Outcomes

Primary Outcome Measures

Assessment of coagulation using Quantra system.
How Fibrinogen level of the patient is reflected by FCS (Fibrinogen Clot Strength of Quantra)
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

Secondary Outcome Measures

Full Information

First Posted
February 26, 2020
Last Updated
May 6, 2021
Sponsor
University of Maryland, Baltimore
Collaborators
HemoSonics LLC
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1. Study Identification

Unique Protocol Identification Number
NCT04301193
Brief Title
Evaluation of Novel Point of Care Coagulation System in Pregnant Women
Acronym
CCPW
Official Title
Evaluation of Novel Point of Care Coagulation System in Pregnant Women
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
November 1, 2019 (Actual)
Primary Completion Date
July 31, 2020 (Actual)
Study Completion Date
July 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Maryland, Baltimore
Collaborators
HemoSonics LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemorrhage, Coagulation Delay

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pregnant Women
Arm Type
Other
Arm Description
All subjects will have the same intervention. Samples will be taken and manipulated in the laboratory for use of the Hemosonic Qauntra Analyzer
Intervention Type
Device
Intervention Name(s)
Quantra Analyzer
Intervention Description
Subjects blood will be manipulated in the lab and will be tested with the Quantra Analyzer
Primary Outcome Measure Information:
Title
Assessment of coagulation using Quantra system.
Description
How Fibrinogen level of the patient is reflected by FCS (Fibrinogen Clot Strength of Quantra)
Time Frame
Baseline
Title
Determine how other conventional tests such as PT, PTT, and INR relate to clotting time of Quantra.
Description
How PT, PTT, and INR level of the patient is reflected by Clot Strength of Quantra
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bhavani Kodali, MD
Organizational Affiliation
University of Maryland, Baltimore
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Maryland Baltimore
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34859304
Citation
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.
Results Reference
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Evaluation of Novel Point of Care Coagulation System in Pregnant Women

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