HemorrhageCCPWNCT04301193

Evaluation of Novel Point of Care Coagulation System in Pregnant Women

An observational study of Hemorrhage and Coagulation Delay, run by University of Maryland, Baltimore at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 18 to 55 years, women onlyHealthy volunteers can take part
Conditions the study is for: Hemorrhage, Coagulation Delay
What is being tested?: Quantra Analyzer
Type of treatment: Medical device
How many people: 13 participants
Where: 1 siteUnited States
Study dates: 1 Nov 2019to 31 Jul 2020
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
Women only
Healthy volunteers accepted
Adult

Study population: Pregnant women

Who may be able to join

Pregnant woman at 37-41 weeks gestation

Who cannot join

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 locations and contacts

1 site in 1 country.

United States1 site

University of Maryland Baltimore
Baltimore, Maryland, 21201

Other trials in United States

About this study

Official title: Efficacy of Sonorheometry Point of the Care Device in Determining Low Fibrinogen Levels in Pregnant Blood: an Invitro Dilution and Reconstitution Study

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

Read the 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.

Conditions: Hemorrhage, Coagulation Delay
Being tested: Quantra Analyzer
Medical subject headings: Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Quantra AnalyzerDevice
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).

Study groups in NCT04301193
Study group	Role	What they receive
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 Receives: Device: Quantra Analyzer

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
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.
Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Nov 201931 Jul 2020

First posted10 Mar 2020
Study start1 Nov 2019
Primary completion31 Jul 2020
Study completion31 Jul 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HemorrhageStudies of the same condition, open and under way.
More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 13 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04301193
Sponsor's protocol ID: 84317
Acronym: CCPW
Status last verified: Apr 2025
First submitted: 26 Feb 2020
Last updated: 27 Apr 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

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.
PubMed 34859304

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy of Sonorheometry Point of the Care Device in Determining Low Fibrinogen Levels in Pregnant Blood: an Invitro Dilution and Reconstitution Study
ClinicalTrials.gov ID: NCT04301193
Acronym / sponsor ID: CCPW / 84317
Conditions: Hemorrhage, Coagulation Delay
Study type: Observational
Recruitment status: Completed
Enrolment: 13 participants (actual)
Lead sponsor: University of Maryland, BaltimoreUniversity, hospital or other
Collaborators: HemoSonics LLC
Study start: 1 Nov 2019 (actual)
Primary completion: 31 Jul 2020 (actual)
Study completion: 31 Jul 2020 (actual)
First posted: 10 Mar 2020 (actual)
Results: Posted 27 Apr 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Pregnant Women	–	Device: Quantra AnalyzerAll subjects will have the same intervention. Samples will be taken and manipulated in the laboratory for use of the Hemosonic Qauntra Analyzer

Who may qualify

Ages: 18 to 55 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult
Study population: Pregnant women

Key inclusion criteria (1 listed)

Pregnant woman at 37-41 weeks gestation

Key exclusion criteria (8 listed)

Hypertension
Preeclampsia
Gestational diabetes
Preexisting coagulopathy
History of deep vein thrombosis (DVT)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Quantra AnalyzerSubject'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).	Device	Pregnant Women

Primary outcome

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.
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.
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.
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.
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
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.

Results and safety

Results posted to the registry on 27 Apr 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pregnant Women	13	13

Primary outcome: 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.

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.. Mean (Standard Deviation). Unit: mg/dL

Measure	Fibrinogen Concentration in Each Sample n = 13
Baseline values	494 (103)
Diluted with saline	105 (31)
15% reconstituted with non pregnant plasma	137 (23)
15% reconstituted with pregnant plasma	162 (38)
30% reconstituted with non pregnant plasma	162 (25)
30% reconstituted with pregnant plasma	214 (46)
Fully Resuscitated	279 (38)

Fibrinogen Concentration in Each Sample: Correlation - R value: 0.93, p <0.05, Regression, Linear
Fibrinogen Concentration in Each Sample: Correlation - R value: 0.77, p <0.05, Regression, Linear

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

Primary outcome: 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.

Measure	Quantra Measured Clot Stiffness CS n = 13	Quantra Measured FCS (Fibrinogen Contribution to Clot Strength n = 13
Base line values	32.8 (9.8)	4.9 (2.5)
Diluted with saline	6.4 (2.2)	1.1 (0.4)
15% reconstituted with non pregnant plasma	8.5 (1.6)	1.9 (0.5)
15% reconstituted with pregnant plasma	10.9 (3.2)	2.5 (0.9)
30% reconstituted with non pregnant plasma	8.8 (2.1)	2.4 (0.8)
30% reconstituted with pregnant plasma	14.9 (4.5)	3.8 (1.6)
Fully resuscitated	18.9 (4.5)	3.9 (1.5)

Adverse events

Time frame: 2 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pregnant Women	0 of 13 (0%)	0 of 13 (0%)	0 of 13

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 34859304Kodali 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Bhavani Kodali, MD principal investigator

University of Maryland, Baltimore

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Hemorrhage and Coagulation Delay, run by University of Maryland, Baltimore at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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. (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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04301193, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2025.