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NCT Number: NCT07683260

Immune-Inflammatory Markers in Aortic Dissection

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.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Bursa City Hospital

Bursa, Nilufer, 16250, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. in-hospital mortality

    Time frame: From the date of surgery until the date of hospital discharge, assessed up to 100 days.

    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.

  2. Perioperative exitus

    Time frame: the period from the patient's surgery up to the 30th day

    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.

Secondary outcomes

  1. intensive care unit and hospital length of stay

    Time frame: From the date of surgery until the date of intensive care unit discharge, assessed up to 100 days

    to investigate its effect on the length of stay in the intensive care unit and in the hospital in surviving patients.

  2. development of renal failure

    Time frame: the period from the patient's surgery up to the 3rd month

    to investigate its effect on the development of renal failure at the 1st and 3rd months in surviving patients.

  3. intraoperative and postoperative use of blood products

    Time frame: from the time of surgery up to 24 hours thereafter

    The effect of immune-inflammatory indices on intraoperative and postoperative use of blood products will be investigated

Sponsors and collaborators

Lead sponsor

Bursa City Hospital

Other Gov

Registry information

Official study title

Prognostic Value of Systemic Immune-Inflammatory and Nutritional Indices for Mortality and Morbidity in Acute Aortic Dissection: A Single-Center Retrospective Study

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 6, 2026
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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