Early Detection of Brain Injury After Congenital Heart Surgery in Infants

Browse trials for

• Heart Defects, Congenital 991
• Hypoxia, Brain 81

Keywords

• Secretoneurin
• GFAP
• Neuron-specific enolase
• S100B
• UCHL-1
• Neurofilament light chain
• MRI
• Cardiopulmonary bypass

Heart Defects, Congenital

991 studies on the registry are indexed under Heart Defects, Congenital; 251 are open to participants now.

This study's planned enrollment of 30 is below the median of 119 across 440 observational studies indexed under Heart Defects, Congenital.

Lead sponsor

University Medical Centre Ljubljana is the lead sponsor of 296 studies on the registry; 72 are open to participants now.

Study population

Groups and cohorts

• 1 (single cohort; no control group)

  Infants (≤1 year) with congenital heart disease undergoing cardiac surgery requiring extracorporeal circulation.

  Other: Observational study: blood analisys, EEG, MRI

Interventions

• OtherObservational study: blood analisys, EEG, MRI

  Observational study: blood analisys, EEG, MRI

Primary outcomes

1. Concentration of serum brain injury biomarker concentrations (ELISA panel)

   Serum concentrations of secretoneurin, GFAP, NSE, S100B, UCHL-1, neurofilament light chain, and total tau measured in peripheral blood.

   Time frame: 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

   EEG findings assessed within the first 24 hours and on postoperative day 7

   Time frame: Post-op day 0-1 and post-op day 7

3. Presence and types of intracranial injuries seen on brain MRI (subset)

   Presence/type/frequency of brain MRI findings performed in a subset of 15 participants between postoperative week 1 and week 2

   Time frame: Post-op week 1-2.

Publications

• 1. Wernovsky G, Licht DJ. Neurodevelopmental Outcomes in Children With Congenital Heart Disease-What Can We Impact? Pediatr Crit Care Med. 2016 Aug;17(8 Suppl 1):S232-42. 2. Zhu S, Sai X, Lin J, Deng G, Zhao M, Nasser MI, Zhu P. Mechanisms of perioperative brain damage in children with congenital heart disease. Biomed Pharmacother. 2020 Dec;132:110957. 3. Fenton KN, Freeman K, Glogowski K, Fogg S, Duncan KF. The significance of baseline cerebral oxygen saturation in children undergoing congenital heart surgery. Am J Surg. 2005 Aug;190(2):260-3. 4. Hasslacher J, Lehner GF, Harler U, Beer R, Ulmer H, Kirchmair R, Fischer-Colbrie R, Bellmann R, Dunzendorfer S, Joannidis M. Secretoneurin as a marker for hypoxic brain injury after cardiopulmonary resuscitation. Intensive Care Med. 2014 Oct;40(10):1518-27. 5. Wechselberger K, Schmid A, Posod A, Höck M, Neubauer V, Fischer-Colbrie R, Kiechl-Kohlendorfer U, Griesmaier E. Secretoneurin Serum Levels in Healthy Term Neonates and Neonates with Hypoxic-Ischaemic Encephalopathy. Neonatology. 2016;110(1):14-20. 6. Zhang S, Wu M, Peng C, Zhao G, Gu R. GFAP expression in injured astrocytes in rats. Exp Ther Med. 2017 Sep;14(3):1905-1908. 7. Coşkun Çeltik, Betül Acunaş, Naci Öner, Özer Pala,.Neuron-specific enolase as a marker of the severity and outcome of hypoxic ischemic encephalopathy, Brain and Development. 2004;398-402. 8. Snyder-Ramos, S. A., Gruhlke, T., Bauer, H., Bauer, M., Luntz, A. P., Motsch, J., … & Böttiger, B. W. (2004). Cerebral and extracerebral release of protein s100b in cardiac surgical patients. Anaesthesia, 59(4), 344-349. 9. Matuszczak, E., Tylicka, M., Komarowska, M. D., Debek, W. & Hermanowicz, A. Ubiquitin carboxy-terminal hydrolase L1-Physiology and pathology. Cell Biochem. Funct. 38, 533-540 (2020) 10. Kirschen MP, Yehya N, Graham K, Kilbaugh T, Berg RA, Topjian A, Diaz-Arrastia R. Circulating Neurofilament Light Chain Is Associated With Survival After Paediatric Cardiac Arrest. Pediatr Crit Care Me

Individual participant data

Plan to share: Undecided