Modeling Blood Management and Hemolytic Risk in Pediatric Heart Surgery

NCT ID: NCT06721455

Last Updated: 2026-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-08-01

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Heart Surgery Blood Transfusion Hemolysis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Children having heart surgery

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

blood sampling

Intervention Type OTHER

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

Interventions

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blood sampling

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

0 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boston Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Koichi Yuki

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Koichi Yuki, MD

Role: PRINCIPAL_INVESTIGATOR

Boston Children's Hospital

Locations

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Boston Children's Hospital

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jocelyn Booth, BSN

Role: CONTACT

857-218-4585

Rachel Bernier, MPH

Role: CONTACT

857-218-5348

Facility Contacts

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Jocelyn Booth, BSN

Role: primary

857-218-4585

Rachel Bernier, MPH

Role: backup

857-218-5348

Other Identifiers

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IRB-P00049726

Identifier Type: -

Identifier Source: org_study_id

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