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Clinical Trials/NCT07014839
NCT07014839CompletedNot Applicable

Biomarkers Predicting Postimplantation Syndrome After Endovascular Aortic Repair (EVAR) and Thoracic Endovascular Aortic Repair (TEVAR)

Ataturk University2 sites in 1 country300 target enrollmentStarted: January 1, 2018Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
300
Locations
2
Primary Endpoint
Evaluation of Postimplantation Syndrome (PIS) Incidence

Study Overview

Brief Summary

The aim of this observational study is to investigate the relationship between postimplantation syndrome (PIS) and laboratory inflammatory parameters following endovascular aortic repair (EVAR/TEVAR). PIS is a systemic inflammatory response that may occur after EVAR or TEVAR and lacks a standardized clinical definition. This study seeks to determine whether specific laboratory biomarkers-particularly white blood cell count, C-reactive protein (CRP), interleukin levels, and neutrophil-to-lymphocyte ratio (NLR)-can serve as reliable indicators for the diagnosis and assessment of PIS.

Detailed Description

Endovascular repair of thoracic and abdominal aortic aneurysms (EVAR/TEVAR) has become a preferred alternative to open surgical repair due to its association with reduced perioperative morbidity and mortality. However, a notable proportion of patients undergoing these procedures may develop postimplantation syndrome (PIS), a systemic inflammatory response first described in 1999. Despite its clinical relevance, PIS remains poorly defined, with varying diagnostic criteria across the literature.

PIS is typically characterized by postoperative fever, fatigue, and an increase in inflammatory markers such as white blood cell (WBC) count, C-reactive protein (CRP), and interleukin-6 (IL-6). The neutrophil-to-lymphocyte ratio (NLR), a readily obtainable marker from complete blood count tests, has also gained attention as a reliable indicator of systemic inflammation. In contrast, procalcitonin levels in PIS patients often remain within normal limits, helping differentiate PIS from bacterial infections.

In this prospective observational study, 200 patients undergoing elective EVAR or TEVAR procedures under general anesthesia were included. All procedures were performed via bilateral femoral artery access using open femoral incisions. Patients were followed postoperatively and assessed for the development of PIS based on clinical and laboratory parameters.

Body temperature was measured at regular intervals, and inflammatory markers-including CRP, WBC count, IL-6, NLR, and procalcitonin-were recorded preoperatively and at 24, 48, and 72 hours postoperatively. PIS was defined as the presence of fever (>38°C) in association with elevated CRP and/or leukocytosis, in the absence of any clinical or microbiological evidence of infection.

Preliminary results showed that patients who developed PIS had significantly higher postoperative levels of WBC, CRP, IL-6, and NLR, while procalcitonin levels remained normal, supporting a non-infectious inflammatory etiology. Imaging and laboratory evaluations ruled out alternative sources of infection. No significant differences were observed in operative time or graft type between patients with and without PIS.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Evaluation of Postimplantation Syndrome (PIS) Incidence

Time Frame: 0-8 days

PIS is defined as the presence of fever (\>38°C) without an identifiable source of infection, accompanied by leukocytosis (white blood cell count \>12,000/mm³) and/or elevated C-reactive protein (CRP \>7 mg/L). The incidence rate of PIS will be calculated based on the number of patients meeting these diagnostic criteria following EVAR or TEVAR procedures. Unit of Measure: Percentage of participants with PIS (%)

Secondary Outcomes

  • C-reactive Protein (CRP) Level(within first 72 hours postoperatively)
  • White Blood Cell (WBC) Count(within first 72 hours postoperatively)
  • Interleukin-6 (IL-6) Level(within first 72 hours postoperatively)
  • Neutrophil-to-Lymphocyte Ratio (NLR)(within first 72 hours postoperatively)
  • Procalcitonin (PCT) Level(within first 72 hours postoperatively)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

ümit arslan

Associate Professor

Ataturk University

Study Sites (2)

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