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TerminatedNCT05645133Updated Jun 15, 2023

QPlus Pediatric Reference Interval

An observational study in Pediatric ALL and Healthy, sponsored by HemoSonics LLC. Terminated at 1 site in United States. Open to participants aged Up to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-15.

Sponsored by HemoSonics LLC (part of Stago) · Observational

Why this study was terminated
PI relocated to another institution
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
93
Ages
Up to 17 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Pediatric ALL
  • Healthy

Keywords

  • QPlus
  • Quantra
  • Pediatric
  • Reference Range
03

In context

Precursor Cell Lymphoblastic Leukemia-Lymphoma

2,121 studies on the registry are indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma; 492 are open to participants now.

This study's enrollment of 93 is below the median of 120 across 313 observational studies indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma.

Browse Precursor Cell Lymphoblastic Leukemia-Lymphoma studies →

Lead sponsor

HemoSonics LLC is the lead sponsor of 26 studies on the registry; 2 are open to participants now.

First submitted after HemoSonics LLC became part of Stago.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 17 Years
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
93 participants (actual)
Patient registry
No

Interventions

  • DeviceDiagnostic Test

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

    Also known as: Point of Care test, Quantra

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Baseline, after access placement before any procedures

  2. 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

    Time frame: Baseline, after access placement before any procedures

  3. 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

    Time frame: Baseline, after access placement before any procedures

  4. 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

    Time frame: Baseline, after access placement before any procedures

  5. 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

    Time frame: Baseline, after access placement before any procedures

07

Study locations

1 site
  • Nicklaus Childrens Hospital
    Miami, Florida 33155, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 15, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05645133
Lead sponsor
HemoSonics LLC
Responsible party
Sponsor
First posted
Dec 9, 2022
Start date
Feb 27, 2023
Primary completion
Jun 1, 2023
Completion
Jun 10, 2023
Last update
Jun 15, 2023

Study contacts

Christopher Tirotta, MD
principal investigator · Nicklaus Childrens

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.

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