Early Detection of Brain Injury After Congenital Heart Surgery in Infants (NCT07424976) | Clinical Trial Compass
By InvitationNot Applicable
Early Detection of Brain Injury After Congenital Heart Surgery in Infants
Slovenia30 participantsStarted 2024-05-03
Plain-language summary
Infants with congenital heart disease undergoing cardiac surgery with extracorporeal circulation are at risk for perioperative hypoxic-ischaemic brain injury. This prospective, single-centre observational cohort study will evaluate perioperative dynamics of serum biomarkers of neuronal, glial, and axonal injury and relate biomarker patterns to postoperative EEG changes and brain MRI findings, aiming to improve early detection of brain injury and identify children at higher risk of hypoxic encephalopathy.
Who can participate
Age range
10 Days – 1 Year
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Infants/children up to 1 year of age with congenital heart disease undergoing surgery requiring extracorporeal blood circulation (cardiopulmonary bypass).
Exclusion Criteria:
* Congenital heart disease not requiring extracorporeal circulation during surgery
* Inoperable congenital heart defect
* Hypoxic encephalopathy at birth requiring therapeutic hypothermia
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Concentration of serum brain injury biomarker concentrations (ELISA panel)
Timeframe: Within 24 hours pre-op; 1 hour post-op arrival; 24, 48, 72, 96 hours; and 7 days post-op.
2
Number of Participants with postoperative EEG abnormalities
Timeframe: Post-op day 0-1 and post-op day 7
3
Presence and types of intracranial injuries seen on brain MRI (subset)