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Pulmonary Embolism: an Autopsy Study

NCT03887819 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 15

Last updated 2019-03-26

No results posted yet for this study

Summary

BACKGROUND: Pulmonary embolism (PE) is associated to high mortality rate worldwide. However, the diagnosis of PE often results inaccurate. Many cases of PE are incorrectly diagnosed or missed and they are often associated to sudden unexpected death (SUD). In forensic practice, it is important to establish the time of thrombus formation in order to determine the precise moment of death. The autopsy remains the gold standard method for the identification of death cause allowing the determination of discrepancies between clinical and autopsy diagnoses. The aim of our study will be to verify the morphological and histological criteria of fatal cases of PE and evaluate the dating of thrombus formation considering 5 ranges of time.

METHODS: Pulmonary vessels sections will be collected from January 2010 to December 2017. Sections of thrombus sampling will be stained with hematoxylin and eosin. The content of infiltrated cells, fibroblasts and collagen fibers will be scored using a semi-quantitative three-point scale of range values.

Hypothesis: After a macroscopic observation and a good sampling traditional histology, it will be important to identify the time of thrombus formation. We will identify histologically a range of time in the physiopathology of the thrombus (early, recent, recent-medium, medium, old), allowing to determine the dating of thrombus formation and the exact time of death.

Conditions

Interventions

DIAGNOSTIC_TEST

Hystological evaluation

The original tissues samples will be fixed in 10% neutral buffered formalin and embedded in paraffin blocks. Sections (4 μm thick) will be stained with hematoxylin and eosin stain (H\&E) for diagnosis. The immunohistochemistry for anti-LCA, anti-CD68, and anti-CD3 will be performed to identify the inflammatory infiltrate.

Sponsors & Collaborators

  • University of Campania Luigi Vanvitelli

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-01
Primary Completion
2018-06-01
Completion
2019-01-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03887819 on ClinicalTrials.gov