NCT06255496

Brief Summary

This study will assess the performance of the Quantra System with the QStat Cartridge versus standard of care coagulation testing in pregnant women at risk of bleeding at delivery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
296

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2024

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 4, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 13, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

May 9, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2025

Completed
Last Updated

November 14, 2025

Status Verified

November 1, 2025

Enrollment Period

1.3 years

First QC Date

February 4, 2024

Last Update Submit

November 13, 2025

Conditions

Blood Loss MassivePost Partum Hemorrhage

Keywords

QuantraViscoelastic testingCoagulation

Outcome Measures

Primary Outcomes (4)

  • Comparison of Quantra Clot Time to laboratory aPTT test results

    Coagulation function assessed by Quantra Clot Time (CT, sec) and activated partial thromboplastin (aPTT, sec) test

    At the time hemorrhage is suspected, anticipated within 24 hours after birth

  • Comparison of Quantra Fibrinogen Contribution to Clot Stiffness to laboratory coagulation fibrinogen test results

    Coagulation function assessed by Quantra Fibrinogen Contribution to Clot Stiffness (FCS, hPa) and Clauss fibrinogen (mg/dL) test

    At the time hemorrhage is suspected, anticipated within 24 hours after birth

  • Comparison of Quantra Clot Time to ROTEM delta INTEM CT test results

    Coagulation function assessed by Quantra Clot Time (CT, sec) and ROTEM INTEM CT (sec) test

    At the time hemorrhage is suspected, anticipated within 24 hours after birth

  • Comparison of Quantra Fibrinogen Contribution to Clot Stiffness to ROTEM delta FIBTEM test results

    Coagulation function assessed by Quantra Fibrinogen Contribution to Clot Stiffness (FCS, hPa) and ROTEM FIBTEM (mm) test

    At the time hemorrhage is suspected, anticipated within 24 hours after birth

Study Arms (1)

Obstetric Patients

Obstetric patient population at risk of experiencing excessive bleeding around the time of delivery

Diagnostic Test: Quantra Hemostasis Analyzer with the QStat Cartridge

Interventions

Quantra Hemostasis Analyzer with the QStat CartridgeDIAGNOSTIC_TEST

Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care.

Also known as: Quantra System, QStat Cartridge
Obstetric Patients

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant females
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Parturients 18 years or older who are at risk of experiencing an obstetric hemorrhage around the time of delivery.

You may qualify if:

  • Subject is greater than18 years.
  • Subject is pregnant or at least 24 h postpartum
  • Conventional coagulation tests and/or viscoelastic testing are ordered for concern of possible coagulopathy based on one or more clinical scenarios including hemorrhage, suspected or confirmed placental abruption, amniotic fluid embolism, or placenta accreta spectrum
  • Subject or subject's LAR is willing to provide informed consent, either prospectively or by deferred consent.

You may not qualify if:

  • Subject is younger than 18 years old.
  • Subject or subject's LAR is unwilling or unable to provide informed consent, either prospectively or by deferred consent.
  • Subject is incarcerated at the time of the study.
  • Subject is currently enrolled in a distinct study that might confound the results of the proposed study
  • Subject is affected by a condition that, in the opinion of the clinical team, may pose additional risks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

University of Oklahoma Medical Center

Oklahoma City, Oklahoma, 73104, United States

Location

Magee Womens Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

Parkland Health

Dallas, Texas, 75235, United States

Location

University of Utah

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

Postpartum HemorrhageThrombosis

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPuerperal DisordersUterine HemorrhageHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2024

First Posted

February 13, 2024

Study Start

May 9, 2024

Primary Completion

August 15, 2025

Study Completion

October 30, 2025

Last Updated

November 14, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

US(6)