Quantra QPlus in Pediatric Cardiovascular Procedures
ConditionBlood Loss, Surgical
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 18
SponsorHemoSonics LLC
About this trial
This study will evaluate the performance of the Quantra System with the QPlus Cartridge in pediatric patients undergoing cardiovascular procedures.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
The study population includes pediatric patients \<18 years of age that are undergoing cardiovascular procedures.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Quantra System
Diagnostic testDiagnostic device to monitor the coagulation properties of a whole blood sample at the point-of-care.
Treatment groups
160 Participants
are divided into 1 treatment groupGroup A: Pediatric patients1 intervention
Trial outcomes
Primary outcomes
1
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.2
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.3
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.4
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: