This study will evaluate the performance of the Quantra System with the QPlus Cartridge in pediatric patients undergoing cardiovascular procedures.
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
160
Diagnostic device to monitor the coagulation properties of a whole blood sample at the point-of-care.
UCLA Mattel Children's Hospital
Los Angeles, California, United States
Children's Healthcare of Atlanta
Atlanta, Georgia, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Correlation of QPlus CT measurements to ROTEM Sigma INTEM CT
Coagulation function assessed by Quantra and ROTEM sigma
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
Coagulation function assessed by Quantra and ROTEM sigma
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
Coagulation function assessed by Quantra and ROTEM sigma
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
Coagulation function assessed by Quantra and ROTEM sigma
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
Coagulation function assessed by Quantra and TEG 6S
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
Coagulation function assessed by Quantra and TEG 6S
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
Coagulation function assessed by Quantra and TEG 6S
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
Coagulation function assessed by Quantra and TEG 6S
Time frame: 3 TIme Points: 1.Preoperatively, 2.During the procedure, and 3.Postoperatively within 24 hours of the end of the procedure.