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
Sex
ALL
Min age
—
Max age
18 Years
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.
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
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.
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