Evaluation of the Clinical Performance of the Quantra System With the QPlus Cartridge in Pediatric Patients Undergoing Cardiovascular Procedures
HemoSonics LLC
Summary
This study will evaluate the performance of the Quantra System with the QPlus Cartridge in pediatric patients undergoing cardiovascular procedures.
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 coagulati…
Eligibility
- Age range
- Up to 18 years
- Sex
- All
- 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 tea…
Interventions
- Diagnostic TestQuantra System
Diagnostic device to monitor the coagulation properties of a whole blood sample at the point-of-care.
Locations (3)
- UCLA Mattel Children's HospitalLos Angeles, California
- Children's Healthcare of AtlantaAtlanta, Georgia
- Children's Hospital of PhiladelphiaPhiladelphia, Pennsylvania