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QPlus Pediatric Reference Interval

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HemoSonics

Status

Terminated

Conditions

Healthy
Pediatric ALL

Treatments

Device: Diagnostic Test

Study type

Observational

Funder types

Industry

Identifiers

NCT05645133
IIS-005

Details and patient eligibility

About

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

Full 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.

Enrollment

93 patients

Sex

All

Ages

Under 17 years old

Volunteers

Accepts Healthy Volunteers

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

Trial contacts and locations

1

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Central trial contact

Julie Navarro, MSN; Debbie Vice President of Clinical Affairs

Data sourced from clinicaltrials.gov

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