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

NCT06899971 | Not Yet Recruiting

• 1 other identifier: IRB-P00050907
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiac Surgery Requiring Cardiopulmonary Bypass; Brain Injury; Congenital Heart Defect

Outcome Measures

Primary Outcomes (1)

• Characterization of postoperative neurological impairment

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

  24 hours following surgery

Study Arms (1)

Cardiac Surgery Patients

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

Other: Collecting discarded blood samples

Interventions

Collecting discarded blood samples OTHER

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

Cardiac Surgery Patients

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients less than 18 years old undergoing a cardiac surgical procedure at Boston Children's Hospital with cardiopulmonary bypass.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Brain Injuries; Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Koichi Yuki, MD

CONTACT

617-355-6115; koichi.yuki@childrens.harvard.edu

Rachel Bernier, MPH

CONTACT

857-218-5438; rachel.bernier@childrens.harvard.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, MD

Study Record Dates

• First Submitted: March 20, 2025
• First Posted: March 28, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 17, 2026

Record last verified: 2026-03

Locations

US (1)