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Not yet recruiting NCT07597278

Quantra QPlus in Pediatric Cardiovascular Procedures

— Observational Blood Loss, Surgical

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Quantra System.
Who it may be relevant to
Registry conditions: Blood Loss, Surgical. Basic parameters: up to 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • 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.]
  • 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.]
  • 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.]
  • 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.]
  • 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.]
  • 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.]
  • 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.]
  • 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.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 3 centers
  • UCLA Mattel Children's Hospital — Los Angeles
  • Children's Healthcare of Atlanta — Atlanta
  • Children's Hospital of Philadelphia — Philadelphia

Identifiers

NCT: NCT07597278 · HEMCS-051

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗