The Association Between Tau & GFAP and Postoperative Neurological Impairment in Patients Undergoing Cardiac Surgery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Boston Children's Hospital
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Characterization of postoperative neurological impairment
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- — to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Cardiac Surgery Patients
Patients less than 18 years old who undergo cardiac surgical procedures on cardiopulmonary bypass.
Intervention: Collecting discarded blood samples (Other)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Koichi Yuki
Principal Investigator, MD
Boston Children's Hospital