The Association Between Tau & GFAP and Postoperative Neurological Impairment in Patients Undergoing Cardiac Surgery

NCT ID: NCT06899971

Last Updated: 2025-12-16

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

NOT_YET_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-02-01

Study Completion Date

2027-12-31

Brief Summary

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Patients born with heart defects often undergo surgical procedures on a heart lung machine. With improvements in medical and surgical management, their survival has significantly improved, but their brain insult has not been paid much attention. This study is to determine the relationship between specific proteins in the blood and brain injury in patients less than 18-year-old undergoing heart surgery.

Detailed Description

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Conditions

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Cardiac Surgery Requiring Cardiopulmonary Bypass Brain Injury Congenital Heart Defect

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cardiac Surgery Patients

Patients less than 18 years old who undergo cardiac surgical procedures on cardiopulmonary bypass.

Collecting discarded blood samples

Intervention Type OTHER

Discarded blood samples will be collected from routine clinical labs collected before and after surgery.

Interventions

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Collecting discarded blood samples

Discarded blood samples will be collected from routine clinical labs collected before and after surgery.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* less than 18 years old
* undergoing cardiac surgery with cardiopulmonary bypass at Boston Children's Hospital

Exclusion Criteria

* undergoing an emergent procedure and do not have more than 1 hour ahead of time to review the consent
* patient in a moribund condition American Society of Anesthesiology (ASA 5)
* patient with a hematological and/or oncological disease
* Jehovah witnesses
* patient on preoperative mechanical ventilation
Maximum Eligible Age

18 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

Principal Investigator, MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Boston Children's Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Central Contacts

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Koichi Yuki, MD

Role: CONTACT

617-355-6115

Rachel Bernier, MPH

Role: CONTACT

857-218-5438

Facility Contacts

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Koichi Yuki, MD

Role: primary

617-355-6115

Other Identifiers

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IRB-P00050907

Identifier Type: -

Identifier Source: org_study_id