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NCT Number: NCT06899971

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

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.

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Key information

Conditions

Cardiac Surgery Requiring Cardiopulmonary Bypass Brain Diseases Brain Injuries Brain Injury Cardiovascular Abnormalities Cardiovascular Diseases Central Nervous System Diseases Congenital Abnormalities Congenital Heart Defect Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniocerebral Trauma Heart Defects, Congenital Heart Diseases Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Collecting discarded blood samples

Other

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

Primary outcomes

  1. Characterization of postoperative neurological impairment

    Time frame: 24 hours following surgery

    Understand the correlation between measured proinflammatory cytokines and several proteins that are highly expressed in brain cells with postoperative neurological status.

Study contacts

Contact information is provided by the study sponsor or research team.

Koichi Yuki, MD

CONTACT

[email protected]

617-355-6115

Rachel Bernier, MPH

CONTACT

[email protected]

857-218-5438

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Mar 28, 2025
Registry last updated
Mar 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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