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

University of Maryland Baltimore (UMB) logo

University of Maryland Baltimore (UMB)

Status

Completed

Conditions

Hemorrhage
Coagulation Delay

Treatments

Device: Quantra Analyzer

Study type

Observational

Funder types

Other
Industry

Identifiers

Details and patient eligibility

About

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

Full 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.

Enrollment

13 patients

Sex

Female

Ages

18 to 55 years old

Volunteers

Accepts 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

Trial design

13 participants in 1 patient group

Pregnant Women
Description:
All subjects will have the same intervention. Samples will be taken and manipulated in the laboratory for use of the Hemosonic Qauntra Analyzer
Treatment:
Device: Quantra Analyzer

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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