- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07683260
Immune-Inflammatory Markers in Aortic Dissection
Prognostic Value of Systemic Immune-Inflammatory and Nutritional Indices for Mortality and Morbidity in Acute Aortic Dissection: A Single-Center Retrospective Study
Identifying early on which patients with acute aortic dissection require closer monitoring may help with care planning. If simple, inexpensive values obtained from routine blood tests can provide additional information for assessing risk, this knowledge could in the future help physicians follow their patients more effectively. The aim of this study is to investigate this possibility scientifically.
It is based on the evaluation of information obtained from blood tests that are already being performed. Its purpose is to generate general knowledge that may contribute to the care of future patients. The study itself does not change decisions about your treatment; all decisions regarding your treatment and follow-up rest with your doctor, who evaluates your condition in its entirety.
It is designed to evaluate the relationship between preoperative/postoperative systemic immune-inflammatory and nutritional markers (SII, NLR, PLR, CAR, PNI) and indicators of mortality and morbidity (length of stay and changes in kidney function) in patients with acute aortic dissection. The goal is to investigate the potential of easily accessible laboratory parameters to contribute to risk stratification. The relationship between the markers and outcomes will be analyzed using appropriate statistical methods.
This study is based on the evaluation of information in patients' existing medical records and blood tests. The data are processed in accordance with the relevant ethical rules and privacy principles, with patient identity kept confidential. Taking part in the study does not require any additional procedure, additional blood draw, or change in treatment.
Aperçu de l'étude
Statut
Description détaillée
This is a single-center observational study based on a retrospective review of the records of patients who underwent surgical treatment for acute aortic dissection at the Bursa City Hospital Operating Room between January 1, 2022, and March 1, 2026. The study was planned and conducted in accordance with the principles of the Declaration of Helsinki and was approved by the Bursa City Hospital Scientific Research Ethics Committee (Decision No: 2026-12/9).
A total of 127 adult patients who underwent surgical treatment with a diagnosis of acute aortic dissection during the specified period were included in the study. The diagnosis was confirmed through clinical findings and radiological examinations, primarily computed tomography angiography, and the type of dissection was recorded. Inclusion criteria: being 18 years of age or older and having undergone surgical intervention for acute aortic dissection. Patients meeting the following criteria were excluded from the study: those with a diagnosis of chronic aortic dissection; cases with missing preoperative laboratory data or clinical outcome records; patients with hematological malignancies or disorders such as leukemia, lymphoma, or immune thrombocytopenic purpura (ITP); those with chronic inflammatory or autoimmune diseases such as rheumatoid arthritis, systemic lupus erythematosus (SLE), or ankylosing spondylitis; patients with active steroid use, immunosuppressive therapy, or recent chemotherapy; and those diagnosed with decompensated liver failure or end-stage renal disease (ESRD). These exclusion criteria were established to ensure the reliability of the results by eliminating patients with comorbidities or treatments that could directly affect neutrophil, platelet, and lymphocyte counts-the study's primary independent variables.
All data were obtained from the hospital's electronic information system and patient files. Age, gender, dissection type, and left ventricular ejection fraction were recorded as demographic and clinical variables. Preoperative blood values were recorded prior to the surgical intervention. The preoperative laboratory parameters examined included white blood cell (WBC) count, neutrophil, lymphocyte, and platelet counts, hemoglobin, D-dimer, creatine kinase-MB (CK-MB), troponin, creatinine, estimated glomerular filtration rate (eGFR), albumin, and C-reactive protein (CRP) levels. Lactate, partial pressure of carbon dioxide (pCO2), and partial pressure of oxygen (pO2) values were obtained from preoperative arterial blood gas analysis. In surviving patients, postoperative values for the same markers were also calculated.
The composite markers investigated were calculated for each patient using the following formulas based on preoperative laboratory values:
Systemic Immune-Inflammation Index (SII): (neutrophil count × platelet count) / lymphocyte count Neutrophil-to-Lymphocyte Ratio (NLR): neutrophil count / lymphocyte count Platelet-to-Lymphocyte Ratio (PLR): platelet count / lymphocyte count CRP-to-Albumin Ratio (CAR): CRP / albumin Prognostic Nutritional Index (PNI): (10 × serum albumin [g/dL]) + (0.005 × total lymphocyte count [/mm3]) SII × Lactate Composite Index: SII × preoperative arterial lactate (mmol/L) The SII × Lactate composite index was defined to combine systemic inflammatory load (SII) and tissue hypoperfusion/anaerobic metabolism (lactate) into a single value. In surviving patients, postoperative values of SII, NLR, PLR, CAR, and PNI were also calculated using the same formulas and compared with preoperative values.
The primary outcomes of the study were perioperative exitus and in-hospital mortality. Secondary outcomes included length of stay in the intensive care unit and hospital, the development of renal failure in surviving patients, and intraoperative and postoperative blood product usage. Renal failure was evaluated using two separate definitions: (i) eGFR falling below 60 mL/min/1.73 m² at the 1st and/or 3rd postoperative month; (ii) the ratio of the 1st and/or 3rd month postoperative creatinine to preoperative creatinine being greater than 1.5. Renal function parameters during the follow-up period were evaluated only in surviving patients.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Nilufer
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Bursa, Nilufer, Turquie (Türkiye), 16250
- Bursa City Hospital
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- Diagnosis of acute aortic dissection (ICD-10 code I71.0) in the emergency department
- Underwent surgical repair for acute aortic dissection under the specified surgical codes
Exclusion Criteria:
- Diagnosed with acute aortic dissection (ICD-10 code I71.0) in the emergency department but did not undergo surgery
- Hematologic disease (e.g., leukemia, lymphoma, idiopathic thrombocytopenic purpura)
- Chronic inflammatory or autoimmune disease (e.g., rheumatoid arthritis, systemic lupus erythematosus, ankylosing spondylitis)
- Chronic steroid use, immunosuppressive therapy, or recent chemotherapy
- Liver failure (affects platelet production and coagulation factors)
- End-stage renal disease requiring hemodialysis
- Missing result in any of the neutrophil, lymphocyte, or platelet blood tests
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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Patients who underwent surgery due to aortic dissection
The diagnosis was confirmed by clinical findings and radiological examinations, primarily computed tomography angiography, and the dissection type was recorded.
Inclusion criteria were being 18 years of age or older and having undergone surgical intervention for acute aortic dissection.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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in-hospital mortality
Délai: From the date of surgery until the date of hospital discharge, assessed up to 100 days.
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These are deaths not related to aortic dissection that occur after surgery in patients who have not yet been discharged from the hospital but have been transferred to another clinic for a different reason.
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From the date of surgery until the date of hospital discharge, assessed up to 100 days.
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Perioperative exitus
Délai: the period from the patient's surgery up to the 30th day
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It refers to the patients in whom perioperative death occurred among those who underwent surgery for acute aortic dissection.These are the patients who died due to aortic dissection after surgery, before being discharged from the hospital and without being transferred to another clinic for a different reason.
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the period from the patient's surgery up to the 30th day
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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intensive care unit and hospital length of stay
Délai: From the date of surgery until the date of intensive care unit discharge, assessed up to 100 days
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to investigate its effect on the length of stay in the intensive care unit and in the hospital in surviving patients.
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From the date of surgery until the date of intensive care unit discharge, assessed up to 100 days
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development of renal failure
Délai: the period from the patient's surgery up to the 3rd month
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to investigate its effect on the development of renal failure at the 1st and 3rd months in surviving patients.
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the period from the patient's surgery up to the 3rd month
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intraoperative and postoperative use of blood products
Délai: from the time of surgery up to 24 hours thereafter
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The effect of immune-inflammatory indices on intraoperative and postoperative use of blood products will be investigated
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from the time of surgery up to 24 hours thereafter
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: esat demirel, MD, Bursa City Hospital
Publications et liens utiles
Publications générales
- Liu G, Wang H, Luo Q, Cao L, Yang L, Yu C, Yan F, Yuan S. Low postoperative blood platelet count may be a risk factor for 3-year mortality in patients with acute type A aortic dissection. J Cardiothorac Surg. 2021 Sep 27;16(1):274. doi: 10.1186/s13019-021-01623-7.
- Larsson M, Zindovic I, Sjogren J, Svensson PJ, Strandberg K, Nozohoor S. A prospective, controlled study on the utility of rotational thromboelastometry in surgery for acute type A aortic dissection. Sci Rep. 2022 Nov 8;12(1):18950. doi: 10.1038/s41598-022-23701-z.
- Bedel C, Selvi F. Association of Platelet to Lymphocyte and Neutrophil to Lymphocyte Ratios with In-Hospital Mortality in Patients with Type A Acute Aortic Dissection. Braz J Cardiovasc Surg. 2019 Dec 1;34(6):694-698. doi: 10.21470/1678-9741-2018-0343.
- Kalkan ME, Kalkan AK, Gundes A, Yanartas M, Ozturk S, Gurbuz AS, Ozturk D, Iyigun T, Akcakoyun M, Emiroglu MY, Tuncer MA, Koksal C. Neutrophil to lymphocyte ratio: a novel marker for predicting hospital mortality of patients with acute type A aortic dissection. Perfusion. 2017 May;32(4):321-327. doi: 10.1177/0267659115590625. Epub 2015 Oct 14.
- Xin Y, Lyu S, Wang J, Wang Y, Shu Y, Liang H, Yang Y. Predictive value of inflammatory indexes in in-hospital mortality for patients with acute aortic dissection. BMC Cardiovasc Disord. 2025 Apr 25;25(1):323. doi: 10.1186/s12872-025-04775-9.
- Xu H, Wang H, Wu L, Xu T, Han L, Lu F, Li B, Sun Y, Xu Z. Prognostic Value of Systemic Inflammation Response Index in Acute Type A Aortic Dissection. World J Surg. 2023 Oct;47(10):2554-2561. doi: 10.1007/s00268-023-07079-1. Epub 2023 May 28.
- Xu H, Li Y, Wang H, Yuan Y, Chen D, Sun Y, Xu Z. Systemic immune-inflammation index predicted short-term outcomes in ATAD patients undergoing surgery. J Card Surg. 2022 Apr;37(4):969-975. doi: 10.1111/jocs.16300. Epub 2022 Feb 10.
- Puluca N, Konig C, Wiesner G, Waschulzik B, Vitanova K, Krane M, Bohm J. Preoperative Hyperlactatemia Predicts Mortality in Acute Stanford Type A Dissection: A 16-Year-Period, Single-Center, Retrospective Study. J Clin Med. 2025 May 22;14(11):3619. doi: 10.3390/jcm14113619.
- Akutsu H, Kawahito K. Preoperative Blood Lactate Level as a Simple Point-of-Care Predictor of Surgical Mortality in Acute Type A Aortic Dissection. Ann Thorac Cardiovasc Surg. 2025;31(1):25-00087. doi: 10.5761/atcs.oa.25-00087.
- Yu D, Chen P, Zhang X, Wang H, Dhuromsingh M, Wu J, Qin B, Guo S, Zhang B, Li C, Zeng H. Association of lymphopenia and RDW elevation with risk of mortality in acute aortic dissection. PLoS One. 2023 Mar 15;18(3):e0283008. doi: 10.1371/journal.pone.0283008. eCollection 2023.
- Alexopoulos D, Xenogiannis I, Vlachakis P, Tantry U, Gurbel PA. Peri-Procedural Platelet Reactivity in Percutaneous Coronary Intervention. Thromb Haemost. 2018 Jul;118(7):1131-1140. doi: 10.1055/s-0038-1649484. Epub 2018 Jun 4.
- Li L, Ma Y, Geng XB, Tan Z, Wang JH, Cui C, Wang HL, Shang XM. Platelet-to-lymphocyte ratio relates to poor prognosis in elderly patients with acute myocardial infarction. Aging Clin Exp Res. 2021 Mar;33(3):619-624. doi: 10.1007/s40520-020-01555-7. Epub 2020 Apr 16.
- Mehta RH, Suzuki T, Hagan PG, Bossone E, Gilon D, Llovet A, Maroto LC, Cooper JV, Smith DE, Armstrong WF, Nienaber CA, Eagle KA; International Registry of Acute Aortic Dissection (IRAD) Investigators. Predicting death in patients with acute type a aortic dissection. Circulation. 2002 Jan 15;105(2):200-6. doi: 10.1161/hc0202.102246.
- Wundram M, Falk V, Eulert-Grehn JJ, Herbst H, Thurau J, Leidel BA, Goncz E, Bauer W, Habazettl H, Kurz SD. Incidence of acute type A aortic dissection in emergency departments. Sci Rep. 2020 May 4;10(1):7434. doi: 10.1038/s41598-020-64299-4.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- E- 2026-12/9
Plan pour les données individuelles des participants (IPD)
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Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
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