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NCT Number: NCT07447713

Reference Range Study for the Quantra System With the QPlus Cartridge in Pediatric Patients

This study will determine reference range intervals for the parameters reported by the Quantra System with the QPlus Cartridge in pediatric patients.

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Key information

Conditions

Pediatric Cardiovascular Diseases Coagulation Embolism and Thrombosis Thrombosis Vascular Diseases

Age range

Up to 17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Children's Hospital Zurich, Zurich, Switzerland

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About this study

The hemostatic profile of an infant is different than that of an adult and changes with age. Most differences occur within the first 6 months of age, with coagulation function similar to that of an adult within the first year of life. To assess the clinical utility of the Quantra System in pediatric patients that are bleeding or at risk for bleeding, it is important to understand the normal reference intervals for the parameters reported by the QPlus Cartridge in normal, healthy pediatric patients.

Who can participate

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

Inclusion criteria

  • Subject is <18 years of age
  • Corrected gestational age ≥ 37weeks
  • Subject is scheduled for an elective surgery, non-surgical intervention or diagnostic procedure requiring anesthesia and vascular access with an ASA score ≤3.
  • Subject's parent or guardian has signed an informed consent form. If required, subject has signed an assent form.

Exclusion criteria

  • Subject is hospitalized in the Pediatric Intensive Care Unit
  • Subject requires Extracorporeal Membrane Oxygenation (ECMO)
  • Subject has had an infection within 7 days of the scheduled procedure
  • Subject has an active coagulation disorder (bleeding or thrombosis)
  • For subjects that have a hemoglobin measurement within 24 hours of the scheduled procedure, hemoglobin is <8g/dL or >16g/dL
  • Subject has a baseline oxygen saturation <92%

Treatment and study plan

Quantra System

Diagnostic Test

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

Primary outcomes

  1. Reference range intervals for measurement of Clot Time (CT) parameter

    Time frame: Baseline, determined from a single blood draw

    Reference range intervals for CT in pediatric patients

  2. Reference range intervals for measurement of Clot Time with Heparinase (CTH) parameter

    Time frame: Baseline, determined from a single blood draw.

    Reference range intervals for CTH in pediatric patients

  3. Reference range intervals for measurement of Clot Stiffness (CS) parameter

    Time frame: Baseline, determined from a single blood draw

    Reference range intervals for CS in pediatric patients

  4. Reference range intervals for measurement of Fibrinogen Contribution (FCS) parameter

    Time frame: Baseline, determined from a single blood draw

    Reference range intervals for FCS in pediatric patients

  5. Reference range intervals for measurement of Platelet Contribution (PCS) parameter

    Time frame: Baseline, determined from a single blood draw

    Reference range intervals for PCS in pediatric patients

Study contacts

Contact information is provided by the study sponsor or research team.

Deborah Winegar, PhD

CONTACT

[email protected]

19192446990

Sponsors and collaborators

Lead sponsor

HemoSonics LLC

Industry

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 3, 2026
Registry last updated
Mar 3, 2026

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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