NCT05875987

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 28, 2023

Completed
27 days until next milestone

First Posted

Study publicly available on registry

May 25, 2023

Completed
7 days until next milestone

Study Start

First participant enrolled

June 1, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2024

Completed
Last Updated

May 13, 2024

Status Verified

May 1, 2024

Enrollment Period

10 months

First QC Date

April 28, 2023

Last Update Submit

May 10, 2024

Conditions

Blood Loss MassivePost Operative 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 the OB hemorrhage protocol is activated, anticipated with 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 the OB hemorrhage protocol is activated, anticipated with 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 the OB hemorrhage protocol is activated, anticipated with 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 the OB hemorrhage protocol is activated, anticipated with 24 hours after birth

Study Arms (1)

Obstetric Patients

Obstetric patient population experiencing excessive bleeding around the time of delivery

Device: Quantra System

Interventions

Quantra SystemDEVICE

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

Also known as: QStat Cartridge
Obstetric Patients

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant females
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Pparturients 18 years or older who experience an obstetric hemorrhage around the time of delivery or cumulatively over 24h after delivery or unstable vital signs or clinical signs of a coagulopathy managed with activation of the stage 2 OB hemorrhage protocol.

You may qualify if:

  • Subject is \> 18 years.
  • Subject is pregnant or at least 24 h postpartum
  • Subject is fluent in English language.
  • Subject is experiencing significant bleeding resulting in activation of the stage 2 OB hemorrhage protocol as defined by blood loss ≥1500ml at delivery or within the first 24 hours after delivery, and/or is hemodynamically unstable and/or is experiencing increased abnormal bleeding not responsive to OB stage 1 hemorrhage resuscitation.
  • Subject or subject's legally authorized representative (LAR) is willing to provide informed consent, either prospectively or by deferred consent.

You may not qualify if:

  • 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 (1)

Duke University Hospital

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Postoperative HemorrhageThrombosis

Condition Hierarchy (Ancestors)

HemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsPostoperative ComplicationsEmbolism 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

April 28, 2023

First Posted

May 25, 2023

Study Start

June 1, 2023

Primary Completion

March 31, 2024

Study Completion

May 10, 2024

Last Updated

May 13, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)