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NCT Number: NCT07597278

Quantra QPlus in Pediatric Cardiovascular Procedures

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

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Key information

Conditions

Blood Loss, Surgical Hemorrhage Intraoperative Complications Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

UCLA Mattel Children's Hospital, Los Angeles, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Quantra System

Diagnostic Test

Diagnostic device to monitor the coagulation properties of a whole blood sample at the point-of-care.

Primary outcomes

  1. 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

  2. Correlation of QPlus CTH measurements to ROTEM Sigma HEPTEM CT

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

    Coagulation function assessed by Quantra and ROTEM sigma

  3. Correlation of QPlus CS measurements to ROTEM Sigma EXTEM A10

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

    Coagulation function assessed by Quantra and ROTEM sigma

  4. Correlation of QPlus FCS measurements to ROTEM Sigma FIBTEM A10

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

    Coagulation function assessed by Quantra and ROTEM sigma

  5. Correlation of QPlus CT to TEG 6S CK-R

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

    Coagulation function assessed by Quantra and TEG 6S

  6. Correlation of QPlus CTH to TEG 6S CKH-R

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

    Coagulation function assessed by Quantra and TEG 6S

  7. Correlation of QPlus CS to TEG 6S CKH-MA

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

    Coagulation function assessed by Quantra and TEG 6S

  8. Correlation of QPlus FCS to TEG 6S FFH-MA

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

    Coagulation function assessed by Quantra and TEG 6S

Study contacts

Contact information is provided by the study sponsor or research team.

Deborah Winegar

CONTACT

[email protected]

9192446990

Sponsors and collaborators

Lead sponsor

HemoSonics LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 19, 2026
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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