Clinical trial NCT04301193: Evaluation of Novel Point of Care Coagulation System in Pregnant Women
Official title: Efficacy of Sonorheometry Point of the Care Device in Determining Low Fibrinogen Levels in Pregnant Blood: an Invitro Dilution and Reconstitution Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemorrhage
Coagulation Delay
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
Collaborators: name: HemoSonics LLC
First posted: 2020-03-10
Enrollment: 13
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women

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.

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

Primary outcomes:
measure: 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.
timeFrame: 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.
measure: 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.
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland Baltimore
state: Maryland
Study officials:
affiliation: University of Maryland, Baltimore
name: Bhavani Kodali, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.