Trial Outcomes & Findings for Evaluation of Novel Point of Care Coagulation System in Pregnant Women (NCT NCT04301193)

Last Updated: 2025-04-27

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

13 participants

Primary outcome 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.

Results posted on

2025-04-27

Participant Flow

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	13
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of Novel Point of Care Coagulation System in Pregnant Women

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pregnant Women n=13 Participants 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
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	31 years STANDARD_DEVIATION 6.5 • n=5 Participants
Sex/Gender, Customized Female	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	13 participants n=5 Participants

PRIMARY outcome

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.

Population: 89 samples were obtained from 13 subjects as explained above.

Outcome measures

Outcome measures
Measure	Fibrinogen Concentration in Each Sample n=89 Samples Blood obtained from pregnant patients served as baseline. The samples were diluted with saline and reconstituted with plasma to obtain varying levesl of fibrinogen. Fibrinogen was measured in the lab and Quantra Analyzer measured CS and FCS	Quantra Measured FCS (Fibrinogen Contribution to Clot Strength Blood obtained from pregnant patients served as baseline. The samples were diluted with saline and reconstituted with plasma.
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	—
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	—
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	—
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	—
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	—
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	—
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	—

PRIMARY outcome

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.

Outcome measures

Outcome measures
Measure	Fibrinogen Concentration in Each Sample n=89 Samples Blood obtained from pregnant patients served as baseline. The samples were diluted with saline and reconstituted with plasma to obtain varying levesl of fibrinogen. Fibrinogen was measured in the lab and Quantra Analyzer measured CS and FCS	Quantra Measured FCS (Fibrinogen Contribution to Clot Strength n=89 Samples Blood obtained from pregnant patients served as baseline. The samples were diluted with saline and reconstituted with plasma.
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	1.1 hPa Standard Deviation 0.4
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	1.9 hPa Standard Deviation 0.5
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	2.5 hPa Standard Deviation 0.9
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	3.9 hPa Standard Deviation 1.5
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	4.9 hPa Standard Deviation 2.5
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	2.4 hPa Standard Deviation 0.8
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	3.8 hPa Standard Deviation 1.6

Adverse Events

Pregnant Women

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Division Chief of Obstetric Anesthesiology

University of Maryland

Phone: (410) 328-4229

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place