QPlus Pediatric Reference Interval

Terminated

• Conditions: Pediatric ALL; Healthy

• Registration Number: NCT05645133
• Lead Sponsor: HemoSonics LLC

Brief Summary

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

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 Timeline

• Study First Submitted: 2022-12-01
• Study First Submitted QC: 2022-12-01
• Study First Posted: 2022-12-09
• Study Start: 2023-02-27
• Status Verified: 2023-06
• Primary Completion: 2023-06-01
• Study Completion: 2023-06-10
• Last Update Submitted: 2023-06-14
• Last Update Posted: 2023-06-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 93

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reference range interval for measurement of clot time (CT) parameter	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 stiffness (CS) parameter	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 Platelet Contribution to clot stiffness (PCS) parameter	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
Reference range interval for measurement of clot time (CTH) parameter	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 Fibrinogen Contribution to clot stiffness (FCS) parameter	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

Trial Locations

Locations (1)

Nicklaus Childrens Hospital; 🇺🇸 Miami, Florida, United States