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
Qualifiers
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 design
Treatments tested in this trial
- Quantra System
Treatment groups
160 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov