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Pediatric ALLNCT05645133

QPlus Pediatric Reference Interval

An observational study of Pediatric ALL and Healthy, run by HemoSonics LLC at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Evaluation of coagulation results reported by the Qplus Quantra System to determine pediatric reference range intervals. Read more about this study

Who is it for?
Ages Up to 17 yearsHealthy volunteers can take part
Conditions the study is for
Pediatric ALL, Healthy
What is being tested?
Diagnostic Test
Type of treatment
Medical device
How many people
93 participants
Where
1 siteUnited States
Study dates
27 Feb 2023to 10 Jun 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 17 years
  • All sexes
  • Healthy volunteers accepted
  • Child

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.

Who may be able to join

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

Who cannot join

  • >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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Nicklaus Childrens Hospital

    Miami, Florida, 33155

Other trials in United States

About this study

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

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.

Being tested
Diagnostic Test
Keywords
QPlus, Quantra, Pediatric, Reference Range
Medical subject headings
Precursor Cell Lymphoblastic Leukemia-Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Diagnostic TestDevice

    Also called Point of Care test, Quantra

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: Baseline, after access placement before any procedures

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2022
  2. Study start27 Feb 2023
  3. Primary completion1 Jun 2023
  4. Study completion10 Jun 2023

Why it stopped: PI relocated to another institution

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
93 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05645133
Sponsor's protocol ID
IIS-005
Status last verified
Jun 2023
First submitted
1 Dec 2022
Last updated
15 Jun 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Pediatric ALL and Healthy, run by HemoSonics LLC at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: PI relocated to another institution). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reference range interval for measurement of clot time (CT) parameter (time frame: Baseline, after access placement before any procedures). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05645133.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2023.

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