Cardiac Surgery Requiring Cardiopulmonary BypassNCT06899971
The Association Between Tau & GFAP and Postoperative Neurological Impairment in Patients Undergoing Cardiac Surgery
An observational study of Cardiac Surgery Requiring Cardiopulmonary Bypass and Brain Injury, run by Boston Children's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Cardiac Surgery Requiring Cardiopulmonary Bypass, Brain Injury, Congenital Heart Defect
- What is being tested?
- Collecting discarded blood samples
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2026to 31 Dec 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients less than 18 years old undergoing a cardiac surgical procedure at Boston Children's Hospital with cardiopulmonary bypass.
Who may be able to join
- less than 18 years old
- undergoing cardiac surgery with cardiopulmonary bypass at Boston Children's Hospital
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Boston Children's Hospital
Boston, Massachusetts, 02115
Koichi Yuki, MD, 617-355-6115, koichi.yuki@childrens.harvard.edu
About this study
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.
- Being tested
- Collecting discarded blood samples
- Medical subject headings
- Brain Injuries, Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collecting discarded blood samplesOther
Discarded blood samples will be collected from routine clinical labs collected before and after surgery.
| Study group | Role | What they receive |
|---|---|---|
| Cardiac Surgery Patients | Patients less than 18 years old who undergo cardiac surgical procedures on cardiopulmonary bypass. Receives: Other: Collecting discarded blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2025
- Study start1 May 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Surgery Requiring Cardiopulmonary BypassStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Koichi Yuki, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06899971
- Sponsor's protocol ID
- IRB-P00050907
- Status last verified
- Mar 2026
- First submitted
- 20 Mar 2025
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No