This study is not yet accepting patients

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

a study on Coagulation

Summary

Eligibility
for people ages up to 17 years (full criteria)
Location
at Los Angeles, California and other locations
Dates
study started
study ends around

Description

Summary

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

Details

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.

Keywords

Pediatric, Coagulation, Reference range, Quantra QPlus, Thrombosis, Quantra System

Eligibility

You can join if…

Open to people ages up to 17 years

  • 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 CAN'T join 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%

Locations

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

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
HemoSonics LLC
ID
NCT07447713
Study Type
Observational
Participants
Expecting 240 study participants
Last Updated