An observational study in Pediatric and Coagulation, sponsored by HemoSonics LLC. Not yet recruiting at 4 sites in 2 countries. Open to participants aged Up to 17 Years. Per ClinicalTrials.gov, last updated 2026-09-17.
Sponsored by HemoSonics LLC (part of Stago) · Observational
This study will determine reference range intervals for the parameters reported by the Quantra System with the QPlus Cartridge in pediatric patients.
The hemostatic profile of an infant is different than that of an adult and changes with age. Most differences occur within the first 6 months of age, with coagulation function similar to that of an adult within the first year of life. To assess the clinical utility of the Quantra System in pediatric patients that are bleeding or at risk for bleeding, it is important to understand the normal reference intervals for the parameters reported by the QPlus Cartridge in normal, healthy pediatric patients.
955 studies on the registry are indexed under Thrombosis; 171 are open to participants now.
This study's planned enrollment of 240 is above the median of 173 across 384 observational studies indexed under Thrombosis.
Browse Thrombosis studies →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.
Children, age birth to \<18 years of age, scheduled for a procedure requiring anesthesia in which vascular access would routinely be placed.
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.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Diagnostic Test: Quantra System
Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care.
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
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.
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
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
Reference range intervals for measurement of Platelet Contribution (PCS) parameter
Reference range intervals for PCS in pediatric patients
Time frame: Baseline, determined from a single blood draw
Plan to share: No
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This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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