Evaluation of the Clinical Performance of the Quantra System With the QPlus Cartridge in Pediatric Patients Undergoing Cardiovascular Procedures

HemoSonics LLC3 sites in 1 country160 target enrollmentStarted: June 25, 2027Last updated: September 17, 2026

Conditions

Interventions

Trial Snapshot

Phase: Not Applicable
Status: Not yet recruiting
Sponsor: HemoSonics LLC
Enrollment: 160
Locations: 3
Primary Endpoint: Correlation of QPlus CT measurements to ROTEM Sigma INTEM CT

Study Overview Study Design Eligibility Criteria Arms & Interventions Outcomes Investigators Sites Records & Identifiers Similar Trials

Study Overview

Brief Summary

This study will evaluate the performance of the Quantra System with the QPlus Cartridge in pediatric patients undergoing cardiovascular procedures.

Detailed Description

Pediatric patients that require major sugical procedures, such as cardiac surgery, are especially vulnerable to perioperative coagulopathy due to age-related immaturity of the hemostatic system, exposure to hemodilution from circuit primes or intravenous volume loading, hypothermia during complex interventions, and the intrinsic bleeding of invasive cardiac procedures. These factors can produce clinically significant perioperative bleeding driven by platelet dysfunction, hypofibrinogenemia and other hemostatic defects. The Quantra System with the QPlus Cartridge is desinged to assess coagulation function of a whole blood sample at the point-of-care by measuring changes in the viscoelastic properties during clot formation. This multi-center study is aimed to demonstrate the performance of the QPlus Cartridge for its ability to aid in the evaluation of a pediatric patient's hemostatic status before, during and after cardiovascular procedures.

Study Design

Study Type: Observational
Observational Model: Cohort
Time Perspective: Prospective

Eligibility Criteria

Ages: — to 18 Years (Child, Adult)
Sex: All
Accepts Healthy Volunteers: No

Inclusion Criteria

•Subject is <18 years of age.
•Subject is undergoing a cardiovascular procedure OR subject underwent cardiovascular surgery and presents with acute bleeding or suspected hypocoagulation/hypercoagulation in a post-surgical unit.
•Subject's parent(s) or guardian(s) has signed an informed consent form. If required, subject has signed an assent form.

Exclusion Criteria

•Corrected gestational age <37 weeks.
•Subject is enrolled in a study that might confound the result of the proposed study.
•Subject is affected by a condition that, in the opinion of the clinical team, may pose additional risks.

Arms & Interventions

Pediatric patients

Pediatric patients undergoing cardiovascular procedures

Intervention: Quantra System (Diagnostic Test)

Outcomes

Primary Outcomes

Correlation of QPlus CT measurements to ROTEM Sigma INTEM CT

Time Frame: 3 TIme Points: 1. 2.During the procedure, and 3.Postoperatively within 24 hours of the end of the procedure.

Coagulation function assessed by Quantra and ROTEM sigma

Correlation of QPlus CTH measurements to ROTEM Sigma HEPTEM CT