Modeling Blood Management and Hemolytic Risk in Pediatric Heart Surgery
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0-17
SponsorBoston Children's Hospital
About this trial
This study aims to learn more about blood management in children undergoing heart surgery, such as the right amounts, and the best blood products, to administer. It also aims to develop a mathematical model that may help researchers better predict and treat patients who need blood transfusions during heart surgery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
pediatric patients under 18 years of age undergoing cardiac surgery with clear prime on cardio-pulmonary bypass (CPB) at Boston Children's Hospital (BCH).
Disqualifiers
patients with known hemolytic disorders, patients on nitric oxide preoperatively, and patients found to have abnormal coagulation on routine preoperative assessment. Patients receiving heparin, American Society of Anesthesia (ASA) status, apixaban, warfarin, or bivalirudin held appropriately (i.e. for elective surgery) will not be excluded
Trial population
Pediatric patients under 18 years of age undergoing cardiac surgery with clear prime on cardio-pulmonary bypass (CPB) at Boston Children's Hospital (BCH).
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
blood sampling
Other interventionDiscarded blood samples will be taken from routine clinical labs drawn during and after heart surgery.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Children having heart surgery1 intervention
Trial outcomes
Primary outcomes
1
Intraoperative hemolysis during pediatric cardiac cardio-pulmonary bypass (CPB) cases as assessed using the plasma free hemoglobin assessment
Time frame
1 day (during cardio-pulmonary bypass)Secondary outcomes
1
In vitro salvaged red blood cells (RBCs) co-incubation with patients' plasma for hemolysis assessment compared to patients' baseline RBCs
Time frame
1 daySponsors and contacts
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Source ClinicalTrials.gov