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Acute Aortic DissectionNCT07683260

Immune-Inflammatory Markers in Aortic Dissection

An observational study of Acute Aortic Dissection and Surgery (Cardiac), run by Bursa City Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 99 years
How many people
127 participants
Where
1 siteTurkey (Türkiye)
Study dates
18 Jun 2026to 23 Jun 2026
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients who underwent surgery for acute aortic dissection in the operating room of Bursa City Hospital

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Bursa City Hospital

    Bursa, Nilufer, 16250

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read more

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.

Read the detailed description

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.

Keywords
Systemic immune-inflammation index (SII), Mortality, Neutrophil-to-lymphocyte ratio (NLR), CRP-to-albumin ratio (CAR), Prognostic Nutritional Index (PNI), acute aort dissection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07683260
Study groupRoleWhat they receive
Patients who underwent surgery due to aortic dissectionThe 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. in-hospital mortality

    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.

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

  2. Perioperative exitus

    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.

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

Secondary outcomes (3)
  1. intensive care unit and hospital length of stay

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

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

  2. development of renal failure

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

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

  3. intraoperative and postoperative use of blood products

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

    Measured: from the time of surgery up to 24 hours thereafter

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jul 2026
  2. Study start18 Jun 2026
  3. Primary completion20 Jun 2026
  4. Study completion23 Jun 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
127 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07683260
Sponsor's protocol ID
E- 2026-12/9
Status last verified
Jun 2026
First submitted
23 Jun 2026
Last updated
6 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared because of ethical and institutional restrictions related to patient confidentiality.

Publications

  • 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.

    PubMed 34579735
  • 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.

    PubMed 36347972
  • 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.

    PubMed 31545575
  • 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.

    PubMed 26467992
  • 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.

    PubMed 40281397
  • 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.

    PubMed 37244873
  • 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.

    PubMed 35141947
  • 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.

    PubMed 40507381
  • 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.

    PubMed 40887214
  • 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.

    PubMed 36920980
  • 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.

    PubMed 29864784
  • 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.

    PubMed 32301030
  • 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.

    PubMed 11790701
  • 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.

    PubMed 32366917

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Aortic Dissection and Surgery (Cardiac), run by Bursa City Hospital at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

in-hospital mortality (time frame: From the date of surgery until the date of hospital discharge, assessed up to 100 days.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07683260, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026; AzTrials last refreshed its copy on 27 Oct 2026.

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