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NCT Number: NCT05409677

Perioperative Eosinophils Their Recovery in Type A Acute Aortic Dissection Prognosis

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

First Affiliated Hospital of Xian JiaotongUniversity, Xi'an, Shaanxi, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

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.

Treatment and study plan

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

Other

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

Primary outcomes

  1. mortality

    Time frame: The first month after operation

    The primary outcome was 1-month mortality

Secondary outcomes

  1. Infection and in-hospital poor prognosis

    Time frame: An average of 1 year

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

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital Xi'an Jiaotong University

Other

Registry information

Official study title

Perioperative Eosinophils And Their Recovery Serve As Prominent Predictors For Type A Acute Aortic Dissection Prognosis

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jun 8, 2022
Registry last updated
Jun 8, 2022

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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