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Modeling Blood Management and Hemolytic Risk in Pediatric Heart Surgery

Mathematical Modeling of Salvaged Red Blood Cells-based Blood Management Strategy and Their Hemolytic Risk in Pediatric Cardiac Surgery

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06721455
Enrollment
50
Registered
2024-12-06
Start date
2025-08-01
Completion date
2026-12-31
Last updated
2026-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Transfusion, Heart Surgery, Hemolysis

Brief summary

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.

Interventions

OTHERblood sampling

Discarded blood samples will be taken from routine clinical labs drawn during and after heart surgery.

Sponsors

Boston Children's Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
0 Years to 17 Years
Healthy volunteers
No

Inclusion criteria

* pediatric patients under 18 years of age undergoing cardiac surgery with clear prime on cardio-pulmonary bypass (CPB) at Boston Children's Hospital (BCH).

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frame
Intraoperative hemolysis during pediatric cardiac cardio-pulmonary bypass (CPB) cases as assessed using the plasma free hemoglobin assessment1 day (during cardio-pulmonary bypass)

Secondary

MeasureTime frame
In vitro salvaged red blood cells (RBCs) co-incubation with patients' plasma for hemolysis assessment compared to patients' baseline RBCs1 day

Countries

United States

Contacts

Primary ContactJocelyn Booth, BSN
jocelyn.booth@childrens.harvard.edu857-218-4585
Backup ContactRachel Bernier, MPH
rachel.bernier@childrens.harvard.edu857-218-5348

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026