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RecruitingNCT06721455Updated Jan 7, 2026

Modeling Blood Management and Hemolytic Risk in Pediatric Heart Surgery

An observational study in Heart Surgery, Blood Transfusion and Hemolysis, sponsored by Boston Children's Hospital. Recruiting at 1 site in United States. Open to participants aged 0 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-01-07.

Sponsored by Boston Children's Hospital · Observational

From the registry’s dates

  • Started Aug 2025; still recruiting 1 year 3 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
0 Years to 17 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Heart Surgery
  • Blood Transfusion
  • Hemolysis

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03

In context

Hemolysis

120 studies on the registry are indexed under Hemolysis; 22 are open to participants now.

This study's planned enrollment of 50 is below the median of 80 across 33 observational studies indexed under Hemolysis.

Browse Hemolysis studies →

Lead sponsor

Boston Children's Hospital is the lead sponsor of 608 studies on the registry; 147 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 19 (59%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
0 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study 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).

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Children having heart surgery

    Children under 18 years of age having heart surgery with cardio-pulmonary bypass at Boston Children's Hospital

    Other: blood sampling

Interventions

  • Otherblood sampling

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

06

What researchers measure

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

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Aug 2025 (actual). Primary completion is estimated for Dec 2026, 16 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 3, 2024
First posted
Dec 6, 2024
StartActual
Aug 1, 2025
Primary completionEst.
Dec 31, 2026
CompletionEst.
Dec 31, 2026
Last update
Jan 7, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06721455
Responsible party
Koichi Yuki (MD, Boston Children's Hospital) — Principal investigator
First posted
Dec 6, 2024
Start date
Aug 1, 2025
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Jan 7, 2026

Study contacts

Jocelyn Booth, BSN
Contact
jocelyn.booth@childrens.harvard.edu
857-218-4585
Rachel Bernier, MPH
Contact
rachel.bernier@childrens.harvard.edu
857-218-5348
Koichi Yuki, MD
principal investigator · Boston Children's Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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