QPlus Pediatric Reference Interval

• Sponsor: HemoSonics LLC (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05645133
• Collaborator: (none)
• Enrollment: 125
• Anticipated Duration (Months): 7

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Pediatric ALL; Healthy	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 Design

• Study Type: Observational
• Anticipated Enrollment: 125 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Evaluation of a Pediatric Reference Interval Using QPLUS System
• Anticipated Study Start Date: Jan 1, 2023
• Anticipated Primary Completion Date: May 1, 2023
• Anticipated Study Completion Date: Aug 1, 2023

Outcome Measures

Primary Outcome Measures

1. 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

2. 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

3. 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

4. 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

5. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• HemoSonics LLC

Investigators

• Principal Investigator: Christopher Tirotta, MD, Nicklaus Childrens

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: HemoSonics LLC
• ClinicalTrials.gov Identifier: NCT05645133
• Other Study ID Numbers: IIS-006
• First Posted: Dec 9, 2022
• Last Update Posted: Jan 9, 2023
• Last Verified: Jan 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by HemoSonics LLC: QPlus; Quantra; Pediatric; Reference Range

Study Results

No Results Posted as of Jan 9, 2023