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NCT05645133 Clinical Trial

QPlus Pediatric Reference Interval

Healthy Clinical Trial

Official title:
Evaluation of a Pediatric Reference Interval Using QPLUS System

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT05645133
Other study ID # IIS-005
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date February 27, 2023
Est. completion date June 10, 2023

Study information
Verified date June 2023
Source HemoSonics LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Terminated
Enrollment 93
Est. completion date June 10, 2023
Est. primary completion date June 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 17 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States Nicklaus Childrens Hospital Miami Florida

Sponsors (1)
Lead Sponsor Collaborator
HemoSonics LLC

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Reference range interval for measurement of clot time (CT) parameter 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
Primary Reference range interval for measurement of clot time (CTH) parameter 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
Primary Reference range interval for measurement of clot stiffness (CS) parameter 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
Primary Reference range interval for measurement of Fibrinogen Contribution to clot stiffness (FCS) parameter 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
Primary Reference range interval for measurement of Platelet Contribution to clot stiffness (PCS) parameter 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
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