Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06721455

Modeling Blood Management and Hemolytic Risk in Pediatric Heart Surgery

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Heart Surgery Blood Transfusion Hemolysis Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

0 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood sampling

Other

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

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 day

Study contacts

Contact information is provided by the study sponsor or research team.

Jocelyn Booth, BSN

CONTACT

[email protected]

857-218-4585

Rachel Bernier, MPH

CONTACT

[email protected]

857-218-5348

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 6, 2024
Registry last updated
Jan 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.