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Reference Range Study for the Quantra System in Pediatric Patients

This study is looking at how the Quantra System with the QPlus Cartridge works in children. The Quantra System is a diagnostic device that helps monitor how blood clots at the point-of-care (meaning, right where you are being treated). We want to find the normal range of clotting measurements (called Clot Time, Clot Time with Heparinase, and Clot Stiffness) for children from birth up to 17 years old. This information is important because children's blood clotting is different from adults' and changes as they grow. This study is currently enrolling 240 participants who are scheduled for an elective surgery, non-surgical intervention, or diagnostic procedure.

Study design
This is an observational study involving 240 participants. It aims to establish normal reference ranges for blood clotting measurements in children.
What's involved
You would have a single blood draw at baseline. This blood sample will be used with the Quantra System to measure clotting properties.
Compensation
Not stated in the trial record.
Follow-up
Not specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07447713

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

Not Yet Recruiting
Not specifiedUp to 17Observational
HemoSonics LLC
~240 participants
Updated 2026-09-17 on ClinicalTrials.gov
What's tested:Quantra System

At a glance

Recruiting sites
0 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Reference range intervals for measurement of Clot Time (CT) parameter
Measured over Baseline, determined from a single blood draw
+4 more outcomes measured

Conditions

Pediatric
Coagulation

Explore related trials

Coagulation

NCT07447713

Where you'd take part

This study runs at 4 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Boston Children's Hospital

    Boston, Massachusettsno site contact published

  • Children's Healthcare of Atlanta

    Atlanta, Georgiano site contact published

  • UCLA Mattel Children's Hospital

    Los Angeles, Californiano site contact published

  • University Children's Hospital Zurich

    Zurich, Switzerlandno site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Deborah Winegar, PhD
[email protected]
19192446990
Email the study team

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Eligibility criteria

Inclusion

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

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%

What this trial measures

  • Reference range intervals for measurement of Clot Time (CT) parameterBaseline, determined from a single blood draw

    Reference range intervals for CT in pediatric patients

  • Reference range intervals for measurement of Clot Time with Heparinase (CTH) parameterBaseline, determined from a single blood draw.

    Reference range intervals for CTH in pediatric patients

  • Reference range intervals for measurement of Clot Stiffness (CS) parameterBaseline, determined from a single blood draw

    Reference range intervals for CS in pediatric patients

  • Reference range intervals for measurement of Fibrinogen Contribution (FCS) parameterBaseline, determined from a single blood draw

    Reference range intervals for FCS in pediatric patients

  • Reference range intervals for measurement of Platelet Contribution (PCS) parameterBaseline, determined from a single blood draw

    Reference range intervals for PCS in pediatric patients