Recruiting

Blood Management

Sponsor:

Boston Children's Hospital

Code:

NCT06721455

Conditions

Heart Surgery

Blood Transfusion

Hemolysis

Eligibility Criteria

Sex: All

Age: 0 - 17

Healthy Volunteers: Not accepted

Interventions

blood sampling

Study Details

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.

Conditions

Heart Surgery

Blood Transfusion

Hemolysis

Study ID

NCT06721455

Start date

Aug 1, 2025

Status verified date

Jan, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 17

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Arms

Children having heart surgery

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

Interventions

blood sampling

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

Primary outcome measure

  • 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) ]

Central Contacts and Locations

Central contacts

Jocelyn Booth, BSN

857-218-4585jocelyn.booth@childrens.harvard.edu

Rachel Bernier, MPH

857-218-5348rachel.bernier@childrens.harvard.edu

Locations

Boston Children's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Jocelyn Booth, BSN

857-218-4585jocelyn.booth@childrens.harvard.edu

Rachel Bernier, MPH

857-218-5348rachel.bernier@childrens.harvard.edu

Principal Investigator:

Koichi Yuki, MD

More Information

Sponsor

Boston Children's Hospital

Last update posted

Jan 7, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Boston Children's Hospital on 2026-01-07.