Clinical Trials in the USA / NCT07597278
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Observational
Quantra QPlus in Pediatric Cardiovascular Procedures
NCT07597278 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Blood Loss, Surgical
Investigational drug(s) / intervention(s)
Quantra System
Quantra System: Diagnostic device to monitor the coagulation properties of a whole blood sample at the point-of-care.
Study summary
This study will evaluate the performance of the Quantra System with the QPlus Cartridge in pediatric patients undergoing cardiovascular procedures.
Eligibility
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.
Primary outcome measure(s)
- Correlation of QPlus CT measurements to ROTEM Sigma INTEM CT — 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 — 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 - Correlation of QPlus CS measurements to ROTEM Sigma EXTEM A10 — 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 - Correlation of QPlus FCS measurements to ROTEM Sigma FIBTEM A10 — 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 - Correlation of QPlus CT to TEG 6S CK-R — 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 - Correlation of QPlus CTH to TEG 6S CKH-R — 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 - Correlation of QPlus CS to TEG 6S CKH-MA — 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 - Correlation of QPlus FCS to TEG 6S FFH-MA — 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
Trial sites (3)
| Facility | City | Region | Status |
|---|---|---|---|
| UCLA Mattel Children's Hospital | Los Angeles | California | |
| Children's Healthcare of Atlanta | Atlanta | Georgia | |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07597278 on ClinicalTrials.gov ↗ ← All trials in the USA