QPlus Pediatric Reference Interval

NCT05645133 | Terminated FDA Device

• 1 other identifier: IIS-005
• Study Type: observational
• Target: 93
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pediatric ALL; Healthy

Keywords

QPlus; Quantra; Pediatric; Reference Range

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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

Interventions

Diagnostic Test DEVICE

Diagnostic device to monitor coagulation properties of a whole blood sample at the point of care

Also known as: Point of Care test, Quantra

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• \<18yrs
• Scheduled for procedure requiring anesthesia
• Access to blood sampling
• Consented

You may not qualify if:

• \>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

Sponsors & Collaborators

• HemoSonics LLC: lead

Study Sites (1)

Nicklaus Childrens Hospital

Miami, Florida, 33155, United States

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Diagnostic Tests, Routine

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Christopher Tirotta, MD

  Nicklaus Childrens

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2022
• First Posted: December 9, 2022
• Study Start: February 27, 2023
• Primary Completion: June 1, 2023
• Study Completion: June 10, 2023
• Last Updated: June 15, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)