- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04918108
Additive Anti-inflammatory Action for Aortopathy & Arteriopathy (Multicenter Retrospective Study) III
October 23, 2021 updated by: Hong Liu, Nanjing Medical University
Inflammatory Response and Anti-inflammatory Action for Aortopathy & Arteriopathy (5A-Plan): A Multicenter Retrospective Study
Anatomopathological classifications have been well identified in aortic dissection with important therapeutic implications.
The authors evaluated the inflammatory response in patients with aortic dissection (AD) and assessed the presence of distinct inflammatory subphenotypes within this disease.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
2000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Jiangsu
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Nanjing, Jiangsu, China, 210029
- The First Affiliated Hospital of Nanjing Medical University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients underwent venipuncture during primary evaluation in the Emergency Department.
Venous blood samples were immediately sent to the laboratory for analysis.
Description
Inclusion Criteria:
- acute type Aortic dissection;
Exclusion Criteria:
- Iatrogenic aortic dissection OR traumatic aortic dissection
- Patients with hematological diseases, infectious diseases, malignant tumors, immune system diseases, or severe liver diseases.
- Preoperative use of mechanical ventilation, blood transfusion, renal replacement therapy, extracorporeal membrane oxygenation, or intra-aortic balloon pump during the current admission.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
inflammatory subphenotype
|
laboratory data (leukocyte, neutrophils, monocyte, lymphocytes, platelet, fibrinogen, D-dimer, neutrophils-lymphocyte ratio, platelet-lymphocyte ratio, lymphocyte-monocyte ratio)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
30-day mortality
Time Frame: 30 days after surgery
|
any cause death within 30 days of surgery
|
30 days after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ICU mortality
Time Frame: 7 days after surgery
|
any cause death within ICU
|
7 days after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Liu H, Qian SC, Han L, Dong ZQ, Shao YF, Li HY, Zhang W, Zhang HJ. Laboratory signatures differentiate the tolerance to hypothermic circulatory arrest in acute type A aortic dissection surgery. Interact Cardiovasc Thorac Surg. 2022 Nov 8;35(6). pii: ivac267. doi: 10.1093/icvts/ivac267.
- Liu H, Qian SC, Zhang YY, Wu Y, Hong L, Yang JN, Zhong JS, Wang YQ, Wu DK, Fan GL, Chen JQ, Zhang SQ, Peng XX, Shao YF, Li HY, Zhang HJ. A Novel Inflammation-Based Risk Score Predicts Mortality in Acute Type A Aortic Dissection Surgery: The Additive Anti-inflammatory Action for Aortopathy and Arteriopathy Score. Mayo Clin Proc Innov Qual Outcomes. 2022 Sep 25;6(6):497-510. doi: 10.1016/j.mayocpiqo.2022.08.005. eCollection 2022 Dec.
- Liu H, Qian SC, Shao YF, Li HY; Additive Anti-inflammatory Action for Aortopathy & Arteriopathy (5A) Investigators Group. Anti-Inflammatory Effect of Ulinastatin on the Association Between Inflammatory Phenotypes in Acute Type A Aortic Dissection. J Inflamm Res. 2022 Jun 27;15:3709-3718. doi: 10.2147/JIR.S369703. eCollection 2022.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2021
Primary Completion (Actual)
August 30, 2021
Study Completion (Actual)
August 30, 2021
Study Registration Dates
First Submitted
June 3, 2021
First Submitted That Met QC Criteria
June 3, 2021
First Posted (Actual)
June 8, 2021
Study Record Updates
Last Update Posted (Actual)
October 26, 2021
Last Update Submitted That Met QC Criteria
October 23, 2021
Last Verified
October 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5A-Plan III
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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