Coagulation Delay, Hemorrhage
Conditions
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.
Interventions
DEVICEQuantra Analyzer
Subject's blood samples will be manipulated in the lab and will be tested with the Quantra Analyzer. After obtaining blood from each patient, the blood was diluted to varying dilutions to obtain different fibrinogen concentrations. This way, 89 samples were prepared from the blood from 13 patients. Each sample was analyzed for fibrinogen concentration in the lab using conventional technology. Additionally each sample was used to measure Quantra variables such as clot stiffness (CS), and fibrinogen contribution to clot stiffness (FCS).
Sponsors
HemoSonics LLC
University of Maryland, Baltimore
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 within 4 hours of preparation. | The Fibrinogen level of the patient in mg/dL is reflected by CS (clost 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pregnant Women All subjects will have the same intervention. Samples will be taken and manipulated in the laboratory for use of the Hemosonic Qauntra Analyzer
Quantra Analyzer: Subjects blood will be manipulated in the lab and will be tested with the Quantra Analyzer | 13 |
| Total | 13 |
Baseline characteristics
| Characteristic | Pregnant Women |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants |
| Age, Continuous | 31 years STANDARD_DEVIATION 6.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 13 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Region of Enrollment United States | 13 participants |
| Sex/Gender, Customized Female | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 13 |
| other Total, other adverse events | 0 / 13 |
| serious Total, serious adverse events | 0 / 13 |
Outcome results
Primary
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.
The Fibrinogen level of the patient in mg/dL is reflected by CS (clost 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.
Time frame: 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.
Population: 89 samples were obtained from 13 subjects as explained above.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fibrinogen Concentration in Each Sample | 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 values | 494 mg/dL | Standard Deviation 103 |
| Fibrinogen Concentration in Each Sample | 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. | Diluted with saline | 105 mg/dL | Standard Deviation 31 |
| Fibrinogen Concentration in Each Sample | 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. | 15% reconstituted with non pregnant plasma | 137 mg/dL | Standard Deviation 23 |
| Fibrinogen Concentration in Each Sample | 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. | 15% reconstituted with pregnant plasma | 162 mg/dL | Standard Deviation 38 |
| Fibrinogen Concentration in Each Sample | 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. | 30% reconstituted with non pregnant plasma | 162 mg/dL | Standard Deviation 25 |
| Fibrinogen Concentration in Each Sample | 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. | 30% reconstituted with pregnant plasma | 214 mg/dL | Standard Deviation 46 |
| Fibrinogen Concentration in Each Sample | 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. | Fully Resuscitated | 279 mg/dL | Standard Deviation 38 |
Comparison: Using standard techniques for estimating sample size, a Delong's test indicated that a total of 61 samples would be sufcient to detect a 0.2 increase in the AUROC from the null hypothesis 0.5, assuming an alpha level of 5% and 90% power \[12\]. The manuscript was referenced against the STROBE checklist for cohort studies. Descriptive statistics were used to present.p-value: <0.05Regression, Linear
p-value: <0.05Regression, Linear
Primary
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.
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.
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fibrinogen Concentration in Each Sample | 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. | 15% reconstituted with non pregnant plasma | 8.5 hPa | Standard Deviation 1.6 |
| Fibrinogen Concentration in Each Sample | 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. | 30% reconstituted with non pregnant plasma | 8.8 hPa | Standard Deviation 2.1 |
| Fibrinogen Concentration in Each Sample | 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. | Diluted with saline | 6.4 hPa | Standard Deviation 2.2 |
| Fibrinogen Concentration in Each Sample | 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. | 30% reconstituted with pregnant plasma | 14.9 hPa | Standard Deviation 4.5 |
| Fibrinogen Concentration in Each Sample | 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. | 15% reconstituted with pregnant plasma | 10.9 hPa | Standard Deviation 3.2 |
| Fibrinogen Concentration in Each Sample | 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. | Fully resuscitated | 18.9 hPa | Standard Deviation 4.5 |
| Fibrinogen Concentration in Each Sample | 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. | Base line values | 32.8 hPa | Standard Deviation 9.8 |
| Quantra Measured FCS (Fibrinogen Contribution to Clot Strength | 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. | Fully resuscitated | 3.9 hPa | Standard Deviation 1.5 |
| Quantra Measured FCS (Fibrinogen Contribution to Clot Strength | 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. | Base line values | 4.9 hPa | Standard Deviation 2.5 |
| Quantra Measured FCS (Fibrinogen Contribution to Clot Strength | 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. | Diluted with saline | 1.1 hPa | Standard Deviation 0.4 |
| Quantra Measured FCS (Fibrinogen Contribution to Clot Strength | 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. | 15% reconstituted with non pregnant plasma | 1.9 hPa | Standard Deviation 0.5 |
| Quantra Measured FCS (Fibrinogen Contribution to Clot Strength | 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. | 15% reconstituted with pregnant plasma | 2.5 hPa | Standard Deviation 0.9 |
| Quantra Measured FCS (Fibrinogen Contribution to Clot Strength | 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. | 30% reconstituted with non pregnant plasma | 2.4 hPa | Standard Deviation 0.8 |
| Quantra Measured FCS (Fibrinogen Contribution to Clot Strength | 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. | 30% reconstituted with pregnant plasma | 3.8 hPa | Standard Deviation 1.6 |