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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association Between Tau & GFAP and Postoperative Neurological Impairment in Patients Undergoing Cardiac Surgery
- ClinicalTrials.gov ID
- NCT06899971
- Acronym / sponsor ID
- IRB-P00050907
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 28 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiac Surgery Patients | – | Other: Collecting discarded blood samplesPatients less than 18 years old who undergo cardiac surgical procedures on cardiopulmonary bypass. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients less than 18 years old undergoing a cardiac surgical procedure at Boston Children's Hospital with cardiopulmonary bypass.
Key inclusion criteria (2 listed)
- less than 18 years old
- undergoing cardiac surgery with cardiopulmonary bypass at Boston Children's Hospital
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collecting discarded blood samplesDiscarded blood samples will be collected from routine clinical labs collected before and after surgery. | Other | Cardiac Surgery Patients |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Surgery Requiring Cardiopulmonary Bypass and Brain Injury, run by Boston Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Koichi Yuki, MD (617-355-6115, koichi.yuki@childrens.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterization of postoperative neurological impairment (time frame: 24 hours following surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026.