QPlus Pediatric Reference Interval

June 14, 2023 updated by: HemoSonics LLC

Evaluation of a Pediatric Reference Interval Using QPLUS System

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

93

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33155
        • Nicklaus Childrens Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 17 years (Child)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Pediatric patients with normal coagulation function who have been scheduled to undergo a procedure and blood sampling access has been established. All genders, racial and ethnic profiles will be described.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline, after access placement before any procedures
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
Baseline, after access placement before any procedures
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
Baseline, after access placement before any procedures
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
Baseline, after access placement before any procedures
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
Baseline, after access placement before any procedures

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HemoSonics LLC

Investigators

  • Principal Investigator: Christopher Tirotta, MD, Nicklaus Childrens

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 27, 2023

Primary Completion (Actual)

June 1, 2023

Study Completion (Actual)

June 10, 2023

Study Registration Dates

First Submitted

December 1, 2022

First Submitted That Met QC Criteria

December 1, 2022

First Posted (Actual)

December 9, 2022

Study Record Updates

Last Update Posted (Actual)

June 15, 2023

Last Update Submitted That Met QC Criteria

June 14, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IIS-005

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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