Quantra QPlus in Pediatric Cardiovascular Procedures

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Blood Loss, Surgical
• Intervention / Treatment: Diagnostic test: Quantra System

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 Type: Observational
• Enrollment (Estimated): 160

Contacts and Locations

• Study Contact: Name: Deborah Winegar; Phone Number: 9192446990; Email: dwinegar@hemosonics.com

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • UCLA Mattel Children's Hospital
  • Georgia
    • Atlanta, Georgia, United States, 30329
      • Children's Healthcare of Atlanta
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Children's Hospital of Philadelphia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population includes pediatric patients <18 years of age that are undergoing cardiovascular procedures.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pediatric patients; Pediatric patients undergoing cardiovascular procedures	Diagnostic test: Quantra System; Diagnostic device to monitor the coagulation properties of a whole blood sample at the point-of-care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation of QPlus CT measurements to ROTEM Sigma INTEM CT	Coagulation function assessed by Quantra and ROTEM sigma	3 TIme Points: 1. 2.During the procedure, and 3.Postoperatively within 24 hours of the end of the procedure.
Correlation of QPlus CTH measurements to ROTEM Sigma HEPTEM CT	Coagulation function assessed by Quantra and ROTEM sigma	3 TIme Points: 1.Preoperatively, 2.During the procedure, and 3.Postoperatively within 24 hours of the end of the procedure.
Correlation of QPlus CS measurements to ROTEM Sigma EXTEM A10	Coagulation function assessed by Quantra and ROTEM sigma	3 TIme Points: 1.Preoperatively, 2.During the procedure, and 3.Postoperatively within 24 hours of the end of the procedure.
Correlation of QPlus FCS measurements to ROTEM Sigma FIBTEM A10	Coagulation function assessed by Quantra and ROTEM sigma	3 TIme Points: 1.Preoperatively, 2.During the procedure, and 3.Postoperatively within 24 hours of the end of the procedure.
Correlation of QPlus CT to TEG 6S CK-R	Coagulation function assessed by Quantra and TEG 6S	3 TIme Points: 1.Preoperatively, 2.During the procedure, and 3.Postoperatively within 24 hours of the end of the procedure.
Correlation of QPlus CTH to TEG 6S CKH-R	Coagulation function assessed by Quantra and TEG 6S	3 TIme Points: 1.Preoperatively, 2.During the procedure, and 3.Postoperatively within 24 hours of the end of the procedure.
Correlation of QPlus CS to TEG 6S CKH-MA	Coagulation function assessed by Quantra and TEG 6S	3 TIme Points: 1.Preoperatively, 2.During the procedure, and 3.Postoperatively within 24 hours of the end of the procedure.
Correlation of QPlus FCS to TEG 6S FFH-MA	Coagulation function assessed by Quantra and TEG 6S	3 TIme Points: 1.Preoperatively, 2.During the procedure, and 3.Postoperatively within 24 hours of the end of the procedure.

Collaborators and Investigators

• Sponsor: HemoSonics LLC

Study record dates

Study Major Dates

• Study Start (Estimated): September 25, 2026
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): October 15, 2027

Study Registration Dates

• First Submitted: May 12, 2026
• First Submitted That Met QC Criteria: May 15, 2026
• First Posted (Actual): May 19, 2026

Study Record Updates

• Last Update Posted (Actual): May 19, 2026
• Last Update Submitted That Met QC Criteria: May 15, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Pediatric; Quantra; Cardiovascular surgery; Viscoelastic testing; QPlus Cartridge
• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage; Intraoperative Complications; Pathological Conditions, Signs and Symptoms; Blood Loss, Surgical
• Other Study ID Numbers: HEMCS-051

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data sharing agreements prevent sharing of IPD.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes