Modeling Blood Management and Hemolytic Risk in Pediatric... | NCT06721455

Studies
Modeling Blood Management and Hemolytic Risk in Pediatric Heart Surgery

NCT06721455

Sponsor

Boston Children's Hospital

Status

Recruiting

Last Update Posted

Jan 7, 2026Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

Heart Surgery
Blood Transfusion
Hemolysis

Interventions

blood sampling

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2025Actual

Primary Completion Date

Dec 31, 2026Estimated

Completion Date

Dec 31, 2026Estimated

First Submitted Date

Dec 3, 2024

First Submission Date that Met QC Criteria

Dec 3, 2024

First Posted Date

Dec 6, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 5, 2026

Last Update Posted Date

Jan 7, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
blood sampling	Other	Discarded blood samples will be taken from routine clinical labs drawn during and after heart surgery.	Children having heart surgery

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Intraoperative hemolysis during pediatric cardiac cardio-pulmonary bypass (CPB) cases as assessed using the plasma free hemoglobin assessment		1 day (during cardio-pulmonary bypass)

Secondary Outcomes

Measure	Description	Time Frame
In vitro salvaged red blood cells (RBCs) co-incubation with patients' plasma for hemolysis assessment compared to patients' baseline RBCs		1 day

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

0 Years

Maximum Age

17 Years

Standard Ages

Child

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).

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jocelyn Booth, BSN	Contact	857-218-4585		jocelyn.booth@childrens.harvard.edu
Rachel Bernier, MPH	Contact	857-218-5348		rachel.bernier@childrens.harvard.edu

Overall Officials

Name	Affiliation	Role
Koichi Yuki, MD	Boston Children's Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Boston Children's Hospital	Recruiting	Boston	Massachusetts	02115	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006461	Hemolysis

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001800	Blood Specimen Collection

Ancestor Terms

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided