QPlus Pediatric Reference Interval

Overview

Evaluation of coagulation results reported by the Qplus Quantra System to determine pediatric reference range intervals.

Full Title of Study: “Evaluation of a Pediatric Reference Interval Using QPLUS System”

Study Type

• Study Type: Observational
• Study Design
  • Time Perspective: Prospective
• Study Primary Completion Date: May 2023

Detailed Description

Single center observational study of the pediatric patient population (< 18yrs) with normal coagulation function to determine the reference range interval for the clotting parameters reported by the Quantra QPlus system.

Interventions

• Device: Diagnostic Test
  • Diagnostic device to monitor coagulation properties of a whole blood sample at the point of care

Clinical Trial Outcome Measures

Primary Measures

• Reference range interval for measurement of clot time (CT) parameter
  • Time Frame: Baseline, after access placement before any procedures
  • Reference range interval determined in this study will serve as the reference for CT results in this particular population
• Reference range interval for measurement of clot time (CTH) parameter
  • Time Frame: Baseline, after access placement before any procedures
  • Reference range interval determined in this study will serve as the reference for CTH results in this particular population
• Reference range interval for measurement of clot stiffness (CS) parameter
  • Time Frame: Baseline, after access placement before any procedures
  • Reference range interval determined in this study will serve as the reference for CS results in this particular population
• Reference range interval for measurement of Fibrinogen Contribution to clot stiffness (FCS) parameter
  • Time Frame: Baseline, after access placement before any procedures
  • Reference range interval determined in this study will serve as the reference for FCS results in this particular population
• Reference range interval for measurement of Platelet Contribution to clot stiffness (PCS) parameter
  • Time Frame: Baseline, after access placement before any procedures
  • Reference range interval determined in this study will serve as the reference for PCS results in this particular population

Participating in This Clinical Trial

Inclusion Criteria

• <18yrs – Scheduled for procedure requiring anesthesia – Access to blood sampling – Consented Exclusion Criteria:

• >18yrs of age – pre-term babies – patients with know hematological disorders – Difficult to obtain blood sampling – Has received a blood product transfusion within the last 24hrs. – Legal guardian unwilling to consent

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: 17 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

• Lead Sponsor
  • HemoSonics LLC
• Provider of Information About this Clinical Study
  • Sponsor
• Overall Official(s)
  • Christopher Tirotta, MD, Principal Investigator, Nicklaus Childrens
• Overall Contact(s)
  • Julie Navarro, MSN, 7577494622, jnavarro@hemosonics.com