Clinical Trials Logo
  1. Home
  2. Healthy
  3. NCT05645133
  4. Details
NCT05645133 Clinical Trial

QPlus Pediatric Reference Interval

Healthy Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT05645133
Other study ID # IIS-005
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date February 27, 2023
Est. completion date June 10, 2023

Study information
Verified date June 2023
Source HemoSonics LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Terminated
Enrollment 93
Est. completion date June 10, 2023
Est. primary completion date June 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 17 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Diagnostic Test
Diagnostic device to monitor coagulation properties of a whole blood sample at the point of care

Locations
Country Name City State
United States Nicklaus Childrens Hospital Miami Florida

Sponsors (1)
Lead Sponsor Collaborator
HemoSonics LLC

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
See also
  Status Clinical Trial Phase
Recruiting NCT06052553 - A Study of TopSpin360 Training Device N/A
Completed NCT05511077 - Biomarkers of Oat Product Intake: The BiOAT Marker Study N/A
Recruiting NCT04632485 - Early Detection of Vascular Dysfunction Using Biomarkers From Lagrangian Carotid Strain Imaging
Completed NCT05931237 - Cranberry Flavan-3-ols Consumption and Gut Microbiota in Healthy Adults N/A
Completed NCT04527718 - Study of the Safety, Tolerability and Pharmacokinetics of 611 in Adult Healthy Volunteers Phase 1
Terminated NCT04556032 - Effects of Ergothioneine on Cognition, Mood, and Sleep in Healthy Adult Men and Women N/A
Completed NCT04107441 - AX-8 Drug Safety, Tolerability and Plasma Levels in Healthy Subjects Phase 1
Completed NCT04065295 - A Study to Test How Well Healthy Men Tolerate Different Doses of BI 1356225 Phase 1
Completed NCT04998695 - Health Effects of Consuming Olive Pomace Oil N/A
Completed NCT01442831 - Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C] TR 701 In Healthy Adult Male Subjects Phase 1
Terminated NCT05934942 - A Study in Healthy Women to Test Whether BI 1358894 Influences the Amount of a Contraceptive in the Blood Phase 1
Recruiting NCT05525845 - Studying the Hedonic and Homeostatic Regulation of Food Intake Using Functional MRI N/A
Completed NCT05515328 - A Study in Healthy Men to Test How BI 685509 is Processed in the Body Phase 1
Completed NCT05030857 - Drug-drug Interaction and Food-effect Study With GLPG4716 and Midazolam in Healthy Subjects Phase 1
Completed NCT04967157 - Cognitive Effects of Citicoline on Attention in Healthy Men and Women N/A
Recruiting NCT04714294 - Evaluate the Safety, Tolerability and Pharmacokinetics Characteristics of HPP737 in Healthy Volunteers Phase 1
Recruiting NCT04494269 - A Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls Phase 1
Completed NCT04539756 - Writing Activities and Emotions N/A
Recruiting NCT04098510 - Concentration of MitoQ in Human Skeletal Muscle N/A
Completed NCT03308110 - Bioavailability and Food Effect Study of Two Formulations of PF-06650833 Phase 1