NCT07683260

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
127

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2026

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 18, 2026

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2026

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

June 23, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 23, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 6, 2026

Completed
Last Updated

July 6, 2026

Status Verified

June 1, 2026

Enrollment Period

2 days

First QC Date

June 23, 2026

Last Update Submit

June 27, 2026

Conditions

Keywords

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

Outcome Measures

Primary Outcomes (2)

  • 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.

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

  • 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.

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

Secondary Outcomes (3)

  • intensive care unit and hospital length of stay

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

  • development of renal failure

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

  • intraoperative and postoperative use of blood products

    from the time of surgery up to 24 hours thereafter

Study Arms (1)

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.

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bursa City Hospital

Bursa, Nilufer, 16250, Turkey (Türkiye)

Location

Related Publications (14)

  • 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.

Study Officials

  • esat demirel, MD

    Bursa City Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 23, 2026

First Posted

July 6, 2026

Study Start

June 18, 2026

Primary Completion

June 20, 2026

Study Completion

June 23, 2026

Last Updated

July 6, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared because of ethical and institutional restrictions related to patient confidentiality.

Locations