Diagnostic Test in Pediatric ALL - Clinical Trials Registry

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Device: Diagnostic Test

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