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CompletedNCT05409677Updated Jun 8, 2022

Perioperative Eosinophils Their Recovery in Type A Acute Aortic Dissection Prognosis

An observational study in Acute Aortic Dissection, sponsored by First Affiliated Hospital Xi'an Jiaotong University. Completed at 2 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-06-08.

Sponsored by First Affiliated Hospital Xi'an Jiaotong University · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
274
Ages
18 Years to 75 Years
Sex
All
01

Study summary

Type A acute aortic dissection (TA-AAD) patients are prone to life-threatening complications and death during the acute phase. Currently, little evidence is available with regards to the relationship between eosinophils (EOS) and TA-AAD.

A total of 274 patients with TA-AAD were eligible for inclusion and 54 patients deceased within 1 month following surgery. Multivariate regression analysis, the general linear model repeated-measures ANOVA analysis (corrected by Greenhouse-Geisser test), receiver-operating characteristics (ROC) curves and a Kaplan-Meier curve were applied for statistical analysis.

Read the detailed description

For this study, 274 patients with TA-AAD admitted into our hospital between February 2019 and July 2021 were enrolled retrospectively. A total of 54 patients deceased unfortunately within 1 month following surgery. We compared baseline sociodemographic, clinical, and functional status based on the main outcome using t tests or Mann-Whitney U test for continuous data and χ2 or Fisher's exact tests for categorical data. Continuous variables were expressed as mean SD median depending on the normality of distribution, and categorical variables were expressed as absolute number along with their percentages and compared using the chi-square test. Multivariate regression analysis was applied to assess the association between EOS and 1-month mortality in an unadjusted model, in an age-, sex-, Body mass index (BMI)-adjusted model (model 2), adjusted for age, sex, BMI, systolic blood pressure (SBP), diastolic blood pressure (DBP) and mean arterial pressure (MAP) (model 3), and further adjusting for age, sex, BMI, SBP, DBP, MAP, heart rate (HR), diabetes, stroke and hyperlipidemia (model 4). In addition, the general linear model repeated-measures ANOVA analysis (Corrected by Greenhouse-Geisser test in nonspherical cases) was used to compare preoperative EOS and postoperative eight-days EOS. For prognostic analysis, receiver-operating characteristics (ROC) curves were used to determine the optimal cutoff of EOS at different points and the time of postoperative EOS to return to normal levels for the prognostic events. A Kaplan-Meier curve was then applied to compare the prognosis between the 2 subgroups based on the predictive threshold. A P value\<0.05 was regarded as statistically significant for all statistical tests.

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Conditions studied

  • Acute Aortic Dissection

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Keywords

  • Type A acute aortic dissection; Eosinophils; Prognosis
03

In context

Aortic Dissection

386 studies on the registry are indexed under Aortic Dissection; 117 are open to participants now.

This study's enrollment of 274 is above the median of 183 across 180 observational studies indexed under Aortic Dissection.

Browse Aortic Dissection studies →

Lead sponsor

First Affiliated Hospital Xi'an Jiaotong University is the lead sponsor of 306 studies on the registry; 86 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The patients were dignosed with Type A acute aortic dissection by the computer tomography between February 2019 and July 2021. A total of 54 patients deceased unfortunately within 1 month following surgery. Depending on mortality within 1 month, the baseline characteristics was compared. Patients were 51.58±11.57 years of age, 203(74.1%) men, and 161(58.8%) with hypertension. There was no discernible difference in gender, BMI, smoking, and alcohol consumption (P>0.05). Moreover, in addition to renal insufficiency, medical histories showed no remarkable deviations between the aforementioned two groups. Non-survivors within 1 month were more likely to have renal insufficiency (6.8% vs. 20.4%; P=0.005).

Inclusion criteria

  • The patients with a diagnosis of Type A acute aortic dissection by the computer tomography

Exclusion criteria

Exclusion Criteria:

  • History of cardiogenic shock or cardiac tamponade;
  • Iatrogenic aortic dissection;
  • Traumatic aortic dissection;
  • Severe valvular disease;
  • Congenital heart disease;
  • Severe organ dysfunction, such as liver and kidney failure;
  • Metabolic diseases such as gout or hyperthyroidism;
  • Malignant tumor;
  • Severe gastrointestinal diseases;
  • Recent drug usage that might affect EOS;
  • Allergic diseases;
  • Infectious diseases;
  • Skin diseases;
  • Hematological diseases, such as leukemia and myelodysplastic syndromes;
  • Immune system diseases.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
274 participants (actual)
Patient registry
No

Groups and cohorts

  • 1-month survivors; 1-month non-survivors

    Depending on mortality within 1 month, the patients were divided into two groups named 1-month survivors and 1-month non-survivors.There was no intervention other than normal treatment

    Other: This was a retrospective study with no intervention other than normal treatment

Interventions

  • OtherThis was a retrospective study with no intervention other than normal treatment

    This was a retrospective study with no intervention other than normal treatment

06

What researchers measure

Primary outcomes

  1. mortality

    The primary outcome was 1-month mortality

    Time frame: The first month after operation

Secondary outcomes

  1. Infection and in-hospital poor prognosis

    Poor prognosis was defined as development of any adverse event including organ injury, delirium, cerebral infarction, cerebral hemorrhage and other cardiovascular and cerebrovascular complications.

    Time frame: An average of 1 year

07

Study locations

2 sites
  • First Affiliated Hospital of Xian JiaotongUniversity
    Xi'an, Shaanxi 710061, China
  • First Affiliated Hospital of Xiann JiaotongUniversity
    Xi'an, Shaanxi 710061, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 8, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05409677
Lead sponsor
First Affiliated Hospital Xi'an Jiaotong University
Responsible party
Sponsor
First posted
Jun 8, 2022
Start date
Feb 1, 2019
Primary completion
Apr 6, 2021
Completion
Jun 7, 2021
Last update
Jun 8, 2022

Study contacts

Yang Yan, Doctor
study chair · First Affiliated Hospital Xi'an Jiaotong University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.

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