Blood Loss, Surgical
Conditions
Keywords
Viscoelastic testing, Quantra, QPlus Cartridge, Pediatric, Cardiovascular surgery
Brief summary
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_TESTQuantra System
Diagnostic device to monitor the coagulation properties of a whole blood sample at the point-of-care.
Sponsors
HemoSonics LLC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
CONTACTDeborah Winegar
Outcome results
None listed