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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pediatric; Coagulation
• Intervention / Treatment: Diagnostic test: Quantra System

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 240

Contacts and Locations

• Study Contact: Name: Deborah Winegar, PhD; Phone Number: 19192446990; Email: dwinegar@hemosonics.com

Study Locations

• Switzerland
  • Zurich, Switzerland, 8008
    • University Children's Hospital Zurich
    • Contact: Department of Anesthesiology
• United States
  • California
    • Los Angeles, California, United States, 90095
      • UCLA Mattel Children's Hospital
      • Contact: Department of Anesthesiology
  • Georgia
    • Atlanta, Georgia, United States, 30329
      • Children's Healthcare of Atlanta
      • Contact: Department of Anesthesiology
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Boston Children's Hospital
      • Contact: Department of Anesthesiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Children, age birth to <18 years of age, scheduled for a procedure requiring anesthesia in which vascular access would routinely be placed.

Description

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%

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pediatric patients	Diagnostic test: Quantra System; Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reference range intervals for measurement of Clot Time (CT) parameter	Reference range intervals for CT in pediatric patients	Baseline, determined from a single blood draw
Reference range intervals for measurement of Clot Time with Heparinase (CTH) parameter	Reference range intervals for CTH in pediatric patients	Baseline, determined from a single blood draw.
Reference range intervals for measurement of Clot Stiffness (CS) parameter	Reference range intervals for CS in pediatric patients	Baseline, determined from a single blood draw
Reference range intervals for measurement of Fibrinogen Contribution (FCS) parameter	Reference range intervals for FCS in pediatric patients	Baseline, determined from a single blood draw
Reference range intervals for measurement of Platelet Contribution (PCS) parameter	Reference range intervals for PCS in pediatric patients	Baseline, determined from a single blood draw

Collaborators and Investigators

• Sponsor: HemoSonics LLC

Study record dates

Study Major Dates

• Study Start (Estimated): April 15, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): May 30, 2027

Study Registration Dates

• First Submitted: February 26, 2026
• First Submitted That Met QC Criteria: February 26, 2026
• First Posted (Actual): March 3, 2026

Study Record Updates

• Last Update Posted (Actual): March 3, 2026
• Last Update Submitted That Met QC Criteria: February 26, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Reference range; Quantra QPlus
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Embolism and Thrombosis; Thrombosis
• Other Study ID Numbers: HEMCS-050

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes