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Completed

NCT Number: NCT05875987

Evaluation of the Quantra QStat System in Obstetric Patients

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.

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Key information

Conditions

Blood Loss Massive Cardiovascular Diseases Embolism and Thrombosis Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms Post Operative Hemorrhage Postoperative Complications Postoperative Hemorrhage Thrombosis Vascular Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Duke University Hospital

Durham, North Carolina, 27710, United States

About this study

The Quantra System is a fully integrated and automated in vitro diagnostic device which uses SEER Sonorheometry, an ultrasound-based technology, to characterize the viscoelastic properties of a whole blood sample during coagulation. The QStat Cartridge was developed to monitor hemostasis in patients that may experience a range of coagulopathies of various etiologies including fibrinolytic defects. These patients include the tobstetric hemorrhage population. The cartridge consists of four independent channels each containing different sets of reagents, which provide four measurements performed in parallel yielding five parameters that depict the functional status of a patient's coagulation system.

This single-center, prospective, observational pilot study will evaluate the performance of the Quantra System with the QStat Cartridge as compared to standard of care coagulation testing in bleeding pregnant women at delivery.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Quantra System

Device

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

Other names: QStat Cartridge

Primary outcomes

  1. Comparison of Quantra Clot Time to laboratory aPTT test results

    Time frame: At the time the OB hemorrhage protocol is activated, anticipated with 24 hours after birth

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

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

    Time frame: At the time the OB hemorrhage protocol is activated, anticipated with 24 hours after birth

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

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

    Time frame: At the time the OB hemorrhage protocol is activated, anticipated with 24 hours after birth

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

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

    Time frame: At the time the OB hemorrhage protocol is activated, anticipated with 24 hours after birth

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

Sponsors and collaborators

Lead sponsor

HemoSonics LLC

Industry

Registry information

Official study title

Pilot Study Evaluating the Clinical Performance of the Quantra With the QStat Cartridge at the Point-of-care in Obstetric Patients

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 25, 2023
Registry last updated
May 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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