Evaluation of Novel Point of Care Coagulation System in Pregnant Women
- Conditions
- HemorrhageCoagulation Delay
- Interventions
- Device: Quantra Analyzer
- Registration Number
- NCT04301193
- Lead Sponsor
- University of Maryland, Baltimore
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 13
- Pregnant woman at 37-41 weeks gestation
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Pregnant Women Quantra Analyzer All subjects will have the same intervention. Samples will be taken and manipulated in the laboratory for use of the Hemosonic Qauntra Analyzer
- Primary Outcome Measures
Name Time Method 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. 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 The Fibrinogen level of the patient in mg/dL is reflected by CS (clot strength measured in hPa) and FCS (Fibrinogen Contribution for Clot Stiffness measured by Quantra measured in hPa). CS and FCS are Quantra measurements of blood clot strength. The higher the CS and FCS, the stronger the clot and the higher the fibrinogen in the blood.
Whole blood samples from pregnant women were diluted with saline to obtain various levels of fibrinogen. The diluted samples were reconstituted with plasma to obtain varying concentrations of fibrinogen. Each sample of the diluted and reconstituted blood was analyzed in the laboratory for fibrinogen level, as well as CS and FCS, using the Qunatra Point of Care system. The correlation between fibrinogen levels and respective CS and FCS was studied. The accuracy of FCS in determining low fibrinogen was the goal of the study. In all 89 samples were obtained from blood obtained from 13 participants.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Maryland Baltimore
🇺🇸Baltimore, Maryland, United States