Evaluation of Novel Point of Care Coagulation System in Pregnant Women

Hemorrhage Clinical Trial

— CCPW  

Official title:

Evaluation of Novel Point of Care Coagulation System in Pregnant Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04301193
• Other study ID #: 84317
• Status: Completed
• Phase: N/A
• Start date: November 1, 2019
• Est. completion date: July 31, 2020

Study information

• Verified date: May 2021
• Source: University of Maryland, Baltimore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: July 31, 2020
• Est. primary completion date: July 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Coagulation Delay
• Hemorrhage

Intervention

Device:
• Quantra Analyzer
Subjects blood will be manipulated in the lab and will be tested with the Quantra Analyzer

Locations

Country	Name	City	State
United States	University of Maryland Baltimore	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
University of Maryland, Baltimore	HemoSonics LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of coagulation using Quantra system.	How Fibrinogen level of the patient is reflected by FCS (Fibrinogen Clot Strength of Quantra)	Baseline
Primary	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