Health TrialsbyHealthPanel

Reference Range Study for the Quantra System With the QPlus Cartridge in Pediatric Patients

ConditionsPediatricCoagulation
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 17
SponsorHemoSonics LLC

About this trial

This study will determine reference range intervals for the parameters reported by the Quantra System with the QPlus Cartridge in pediatric patients.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subject is <18 years of age

Corrected gestational age ≥ 37weeks

Subject is scheduled for an elective surgery, non-surgical intervention or diagnostic procedure requiring anesthesia and vascular access with an ASA score ≤3.

Subject's parent or guardian has signed an informed consent form. If required, subject has signed an assent form.

Disqualifiers

Subject is hospitalized in the Pediatric Intensive Care Unit

Subject requires Extracorporeal Membrane Oxygenation (ECMO)

Subject has had an infection within 7 days of the scheduled procedure

Subject has an active coagulation disorder (bleeding or thrombosis)

Trial population

Children, age birth to \<18 years of age, scheduled for a procedure requiring anesthesia in which vascular access would routinely be placed.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Quantra System

    Diagnostic test

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

Treatment groups

240 Participants
are divided into 1 treatment group
Group A: Pediatric patients1 intervention

Trial outcomes

Primary outcomes

1

Reference range intervals for measurement of Clot Time (CT) parameter

Reference range intervals for CT in pediatric patients

Time frame
Baseline, determined from a single blood draw
2

Reference range intervals for measurement of Clot Time with Heparinase (CTH) parameter

Reference range intervals for CTH in pediatric patients

Time frame
Baseline, determined from a single blood draw.
3

Reference range intervals for measurement of Clot Stiffness (CS) parameter

Reference range intervals for CS in pediatric patients

Time frame
Baseline, determined from a single blood draw
4

Reference range intervals for measurement of Fibrinogen Contribution (FCS) parameter

Reference range intervals for FCS in pediatric patients

Time frame
Baseline, determined from a single blood draw

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

HemoSonics LLC

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: