Postoperative Bleeding Definitions as the Foundation of Hemostasis in Pediatric Cardiac Surgery
Abstract
1. Introduction
2. Why Definitions Matter
3. Adult Bleeding Definitions
4. Current Pediatric Bleeding Definitions
5. Unique Pediatric Physiologic and Surgical Factors
6. Challenges of Chest Tube Output as a Bleeding Measure
7. Inconsistency in Transfusion-Based Definitions
8. Interventions vs. Outcomes in Bleeding Definitions
9. VAD and ECMO Definitions
10. EMR Limitations and Data Capture Problems
11. Why Standardization Matters
12. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
- Guzzetta, N.A.; Allen, N.N.; Wilson, E.C.; Foster, G.S.; Ehrlich, A.C.; Miller, B.E. Excessive Postoperative Bleeding and Outcomes in Neonates Undergoing Cardiopulmonary Bypass. Anesth. Analg. 2015, 120, 405–410. [Google Scholar] [CrossRef] [PubMed]
- Karam, O.; Nellis, M.E.; Zantek, N.D.; Lacroix, J.; Faustino, E.V.S. Criteria for Clinically Relevant Bleeding in Critically Ill Children: An International Survey. Pediatr. Crit. Care Med. 2019, 20, e137–e144. [Google Scholar] [CrossRef] [PubMed]
- Schulman, S.; Kearon, C. Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patients: Definitions of major bleeding in clinical studies. J. Thromb. Haemost. 2005, 3, 692–694. [Google Scholar] [CrossRef] [PubMed]
- Mehran, R.; Rao, S.V.; Bhatt, D.L.; Gibson, C.M.; Caixeta, A.; Eikelboom, J.; Kaul, S.; Wiviott, S.D.; Menon, V.; Nikolsky, E.; et al. Standardized Bleeding Definitions for Cardiovascular Clinical Trials: A Consensus Report from the Bleeding Academic Research Consortium. Circulation 2011, 123, 2736–2747. [Google Scholar] [CrossRef]
- Sabatine, M.S.; Braunwald, E. Thrombolysis In Myocardial Infarction (TIMI) Study Group. J. Am. Coll. Cardiol. 2021, 77, 2822–2845. [Google Scholar] [CrossRef]
- Bercovitz, R.S.; Shewmake, A.C.; Newman, D.K.; Niebler, R.A.; Scott, J.P.; Stuth, E.; Simpson, P.M.; Yan, K.; Woods, R.K. Validation of a definition of excessive postoperative bleeding in infants undergoing cardiac surgery with cardiopulmonary bypass. J. Thorac. Cardiovasc. Surg. 2018, 155, 2112–2124.e2. [Google Scholar] [CrossRef]
- Nellis, M.E.; Tucci, M.; Lacroix, J.; Spinella, P.C.; Haque, K.D.; Stock, A.; Steiner, M.E.; Faustino, E.V.S.; Zantek, N.D.; Davis, P.J.; et al. Bleeding Assessment Scale in Critically Ill Children (BASIC): Physician-Driven Diagnostic Criteria for Bleeding Severity. Crit. Care Med. 2019, 47, 1766–1772. [Google Scholar] [CrossRef]
- Rosenthal, D.N.; Almond, C.S.; Jaquiss, R.D.; Peyton, C.E.; Auerbach, S.R.; Morales, D.R.; Epstein, D.J.; Cantor, R.S.; Kormos, R.L.; Naftel, D.C.; et al. Adverse events in children implanted with ventricular assist devices in the United States: Data from the Pediatric Interagency Registry for Mechanical Circulatory Support (PediMACS). J. Heart Lung Transplant. 2016, 35, 569–577. [Google Scholar] [CrossRef]
- Extracorporeal Life Support Organization (ELSO). ELSO Registry Data Definitions. 2026. Available online: https://www.elso.org/portals/0/files/new%20registry%20elso%20registry%20data%20definitions%2001-05-2026.pdf (accessed on 6 April 2026).
- Alexander, P.M.A.; Di Nardo, M.; Combes, A.; Vogel, A.M.; Antonini, M.V.; Barrett, N.; Benedetti, G.M.; Bettencourt, A.; Brodie, D.; Gómez-Gutiérrez, R.; et al. Definitions of adverse events associated with extracorporeal membrane oxygenation in children: Results of an international Delphi process from the ECMO-CENTRAL ARC. Lancet Child Adolesc. Health 2024, 8, 773–780. [Google Scholar] [CrossRef]
- Xu, Y.; Gomes, T.; Wells, P.S.; Pequeno, P.; Johnson, A.; Sholzberg, M. Evaluation of definitions for oral anticoagulant-associated major bleeding: A population-based cohort study. Thromb. Res. 2022, 213, 57–64. [Google Scholar] [CrossRef]
- Aladangady, N.; Leung, T.; Costeloe, K.; Delpy, D. Measuring circulating blood volume in newborn infants using pulse dye densitometry and indocyanine green. Pediatr. Anesth. 2008, 18, 865–871. [Google Scholar] [CrossRef]
- Rawlings, J.S.; Pettett, G.; Wiswell, T.E.; Clapper, J. Estimated blood volumes in polycythemic neonates as a function of birth weight. J. Pediatr. 1982, 101, 594–599. [Google Scholar] [CrossRef]
- Toulon, P.; Berruyer, M.; Brionne-François, M.; Grand, F.; Lasne, D.; Telion, C.; Arcizet, J.; Giacomello, R.; De Pooter, N. Age dependency for coagulation parameters in paediatric populations: Results of a multicentre study aimed at defining the age-specific reference ranges. Thromb. Haemost. 2016, 116, 9–16. [Google Scholar] [CrossRef]
- Mou, S.S.; Giroir, B.P.; Molitor-Kirsch, E.A.; Leonard, S.R.; Nikaidoh, H.; Nizzi, F.; Town, D.A.; Roy, L.C.; Scott, W.; Stromberg, D. Fresh Whole Blood versus Reconstituted Blood for Pump Priming in Heart Surgery in Infants. N. Engl. J. Med. 2004, 351, 1635–1644. [Google Scholar] [CrossRef] [PubMed]
- Bønding Andreasen, J.; Hvas, A.; Ravn, H.B. Marked changes in platelet count and function following pediatric congenital heart surgery. Pediatr. Anesth. 2014, 24, 386–392. [Google Scholar] [CrossRef] [PubMed]
- Boehne, M.; Sasse, M.; Karch, A.; Dziuba, F.; Horke, A.; Kaussen, T.; Mikolajczyk, R.; Beerbaum, P.; Jack, T. Systemic inflammatory response syndrome after pediatric congenital heart surgery: Incidence, risk factors, and clinical outcome. J. Card. Surg. 2017, 32, 116–125. [Google Scholar] [CrossRef]
- Di Gregorio, G.; Sella, N.; Spiezia, L.; Menin, E.; Boscolo, A.; Pasin, L.; Pittarello, D.; Vida, V.; Simioni, P.; Navalesi, P. Cardiopulmonary bypass-induced coagulopathy in pediatric patients: The role of platelets in postoperative bleeding. A preliminary study. Artif. Organs 2021, 45, 852–860. [Google Scholar] [CrossRef]
- Engelman, D.T.; Ben Ali, W.; Williams, J.B.; Perrault, L.P.; Reddy, V.S.; Arora, R.C.; Roselli, E.E.; Khoynezhad, A.; Gerdisch, M.; Levy, J.H.; et al. Guidelines for Perioperative Care in Cardiac Surgery: Enhanced Recovery After Surgery Society Recommendations. JAMA Surg. 2019, 154, 755. [Google Scholar] [CrossRef]
- Anker, A.M.; Miranda, B.H.; Prantl, L.; Kehrer, A.; Strauss, C.; Brébant, V.; Klein, S.M. 50 Shades of Red: The Predictive Value of Closed Suction Drains for the Detection of Postoperative Bleeding in Breast Surgery. Aesth. Plast. Surg. 2019, 43, 608–615. [Google Scholar] [CrossRef]
- Rothermel, L.D.; Lipman, J.M. Estimation of blood loss is inaccurate and unreliable. Surgery 2016, 160, 946–953. [Google Scholar] [CrossRef] [PubMed]
- Vranckx, P.; White, H.D.; Huang, Z.; Mahaffey, K.W.; Armstrong, P.W.; Van De Werf, F.; Moliterno, D.J.; Wallentin, L.; Held, C.; Aylward, P.E.; et al. Validation of BARC Bleeding Criteria in Patients with Acute Coronary Syndromes. J. Am. Coll. Cardiol. 2016, 67, 2135–2144. [Google Scholar] [CrossRef] [PubMed]
- Laverdière, C.; Gauvin, F.; Hébert, P.C.; Infante-Rivard, C.; Hume, H.; Toledano, B.J.; Guertin, M.-C.; Lacroix, J. Survey on transfusion practices of pediatric intensivists. Pediatr. Crit. Care Med. 2002, 3, 335–340. [Google Scholar] [CrossRef]
- Chishtie, J.; Sapiro, N.; Wiebe, N.; Rabatach, L.; Lorenzetti, D.; Leung, A.A.; Rabi, D.; Quan, H.; Eastwood, C.A. Use of Epic Electronic Health Record System for Health Care Research: Scoping Review. J. Med. Internet Res. 2023, 25, e51003. [Google Scholar] [CrossRef] [PubMed]
- Horner, D.; Rex, S.; Reynard, C.; Bursnall, M.; Bradburn, M.; De Wit, K.; Goodacre, S.; Hunt, B.J. Accuracy of efficient data methods to determine the incidence of hospital-acquired thrombosis and major bleeding in medical and surgical inpatients: A multicentre observational cohort study in four UK hospitals. BMJ Open 2023, 13, e069244. [Google Scholar] [CrossRef]
- Pelletier, J.H.; Maholtz, D.E.; Hanson, C.M.; Nofziger, R.A.; Forbes, M.L.; Besunder, J.B.; Horvat, C.M.; Page-Goertz, C.K. Respiratory Support Practices for Bronchiolitis in the Pediatric Intensive Care Unit. JAMA Netw. Open 2024, 7, e2410746. [Google Scholar] [CrossRef]
- Atchison, C.; Chegondi, M.; Aldairi, N.; Carmona, C.; Mahmood, H.; Levasseur, J.; Funaro, M.C.; Faustino, E.V.S.; Nellis, M.E.; Willems, A.; et al. Bleeding Definitions in Pediatric Extracorporeal Membrane Oxygenation (ECMO) Studies: A Systematic Review and Meta-Analysis. ASAIO J. 2026, 72, 152–158. [Google Scholar] [CrossRef] [PubMed]

| Definition (Reference)/Target Population | Quantitative Blood Loss Criteria | Physiologic/Clinical Impact Criteria | Intervention-Based Criteria | Behavior-Independent? |
|---|---|---|---|---|
| Adult consensus definitions | ||||
| ISTH Major Bleeding, Schulman and Kearon, 2005 [3] Adults on anticoagulation (non-surgical) | Not quantified | Fatal bleeding OR Bleeding in a critical site:
OR Hemoglobin decrease ≥2 g/dL | Transfusion of 2 units of whole blood or packed red blood cells | Partial Critical-site and Hb criteria are behavior-independent; the transfusion criterion is clinician-driven |
| BARC Type 4, Mehran et al., 2011 [4] Adults undergoing coronary artery bypass grafting | Chest tube drainage ≥2 L within 24 h (not weight-indexed) | Perioperative intracranial hemorrhage within 48 h | Any of the following:
| Partial Intracranial hemorrhage and chest tube volume are behavior-independent; reoperation and transfusion criteria are clinician-driven |
| TIMI Major Bleeding, Sabatine and Braunwald, 2021 [5] Adults receiving thrombolytic or antithrombotic therapy | Not quantified | Intracranial hemorrhage OR Hemoglobin decrease ≥5 g/dL OR Hematocrit decrease ≥15% (with or without an identified bleeding site) | Not included | Yes Anchored in intracranial hemorrhage and laboratory findings; no intervention-based criteria |
| Pediatric and mechanical circulatory support definitions | ||||
| Bercovitz et al., 2018 [6] Neonates and infants undergoing cardiac surgery with cardiopulmonary bypass | Chest tube output ≥7 mL/kg/h for ≥2 consecutive hours within the first 12 postoperative hours OR Chest tube output ≥84 mL/kg total within the first 24 postoperative hours | Not included | Surgical re-exploration for bleeding or cardiac tamponade physiology within the first 24 postoperative hours | Partial Volume criteria are behavior-independent; the re-exploration criterion is clinician-driven |
| BASIC, Nellis et al., 2019 [7] All critically ill children (applicable to the post-cardiac-surgery population) | Severe: quantifiable bleeding ≥5 mL/kg/h for ≥1 h Moderate: ≥1 but <5 mL/kg/h Minimal: <1 mL/kg/h | Severe bleeding requires any of the following:
| Explicitly excluded; red cell transfusion and surgical interventions are not part of the definition | Yes |
| PediMACS/INTERMACS, Rosenthal et al., 2016 [8] Children supported by durable ventricular assist devices | Not quantified | Not quantified; death as a qualifying criterion | Major bleeding episode requiring any of:
| No (besides death) Primarily intervention-anchored |
| ELSO Registry, 2026 [9] Children supported by extracorporeal membrane oxygenation | Not expressed as continuous blood loss thresholds. The primary quantitative anchor is transfusion volume (see intervention column) | Events categorized by anatomic site:
| Packed red blood cell transfusion >20 mL/kg/24 h, or >3 units/24 h Endoscopic, radiologic, or surgical interventions required for confirmation of most site-specific events | No Primarily transfusion-anchored, with interventions embedded in site-specific event confirmation |
| ECMO-CENTRAL, Severe (Type 3), Alexander et al., 2024 [10] Children supported by extracorporeal membrane oxygenation | Sustained blood loss >5 mL/kg/h for ≥2 h, OR >40 mL/kg within 24 h For patients >50 kg: >250 mL/h for ≥2 h, OR >2000 mL within 24 h | Volume criteria alone are insufficient. Severe bleeding requires overt bleeding AND ≥2 markers of physiologic or clinical compromise:
Cardiac tamponade or compartment syndrome classified as severe regardless of volume | Not required to meet definition | Partial Quantitative blood loss, Hb/lactate criteria, and critical consequences (tamponade, compartment syndrome) are behavior-independent. Hemodynamic deterioration is not quantitatively defined. Escalation of vasoactive support and volume administration to maintain pump preload are clinician-driven |
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Karam, O.; Atchison, C.; Chegondi, M. Postoperative Bleeding Definitions as the Foundation of Hemostasis in Pediatric Cardiac Surgery. Diagnostics 2026, 16, 1375. https://doi.org/10.3390/diagnostics16091375
Karam O, Atchison C, Chegondi M. Postoperative Bleeding Definitions as the Foundation of Hemostasis in Pediatric Cardiac Surgery. Diagnostics. 2026; 16(9):1375. https://doi.org/10.3390/diagnostics16091375
Chicago/Turabian StyleKaram, Oliver, Christie Atchison, and Madhuradhar Chegondi. 2026. "Postoperative Bleeding Definitions as the Foundation of Hemostasis in Pediatric Cardiac Surgery" Diagnostics 16, no. 9: 1375. https://doi.org/10.3390/diagnostics16091375
APA StyleKaram, O., Atchison, C., & Chegondi, M. (2026). Postoperative Bleeding Definitions as the Foundation of Hemostasis in Pediatric Cardiac Surgery. Diagnostics, 16(9), 1375. https://doi.org/10.3390/diagnostics16091375

