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

NCT07447713 | Not Yet Recruiting FDA Device

• 1 other identifier: HEMCS-050
• Study Type: observational
• Target: 240
• Locations: 2 countries
• Sites: 4

Brief Summary

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

Conditions

Pediatric; Coagulation

Keywords

Reference range; Quantra QPlus

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (1)

Pediatric patients

Diagnostic Test: Quantra System

Interventions

Quantra System DIAGNOSTIC_TEST

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

Pediatric patients

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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%

Sponsors & Collaborators

• HemoSonics LLC: lead

Study Sites (4)

UCLA Mattel Children's Hospital

Los Angeles, California, 90095, United States

Location

Children's Healthcare of Atlanta

Atlanta, Georgia, 30329, United States

Location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

University Children's Hospital Zurich

Zurich, 8008, Switzerland

Location

MeSH Terms

Conditions

Thrombosis

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Deborah Winegar, PhD

CONTACT

19192446990; dwinegar@hemosonics.com

Study Design

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

Study Record Dates

• First Submitted: February 26, 2026
• First Posted: March 3, 2026
• Study Start (Estimated): March 15, 2027
• Primary Completion (Estimated): January 30, 2028
• Study Completion (Estimated): March 30, 2028
• Last Updated: September 17, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1); US (3)